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Latest Biologics License Application Stock News

Adaptimmune Therapeutics Completes Submission of Rolling Biologics License Application (BLA) to U.S. FDA for Afami-cel for the Treatment of Advanced Synovial Sarcoma

December 6
Last Trade: 0.54 -0.03 -4.39

First BLA for an engineered T-cell therapy for solid tumors submitted to U.S. Food and Drug Administration Afami-cel data demonstrate better outcomes for people with synovial sarcoma compared to historical control data; pivotal trial has met primary endpoint for efficacy Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - December 6, 2023) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy...Read more


U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic...

December 5
Last Trade: 50.31 0.15 0.30

Application based on results from the Phase 3 CheckMate -901 trial showing significant survival improvement vs. standard-of-care gemcitabine plus cisplatin in cisplatin-eligible patients with untreated, unresectable or metastatic urothelial carcinoma If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the U.S. The U.S. Food and Drug Administration...Read more


FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer

December 5
Last Trade: 29.21 -0.16 -0.54

Priority Review Granted with PDUFA Date of April 5, 2024 WALTHAM, Mass. / Dec 05, 2023 / Business Wire / ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has filed the supplemental Biologics License Application (sBLA) supporting the conversion of the accelerated approval of ELAHERE® (mirvetuximab...Read more


FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

November 30
Last Trade: 103.75 -0.13 -0.13

Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus chemotherapy in these patients RAHWAY, N.J. / Nov 30, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for...Read more


Seagen: FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

November 30
Last Trade: 218.98 0.65 0.30

Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progression-free survival vs standard platinum containing chemotherapy If approved, the combination would be the first and only antibody-drug conjugate plus PD-1 inhibitor treatment alternative to chemotherapy in this patient population  TOKYO and BOTHELL, Wash., Nov. 30, 2023...Read more


Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)

November 27
Last Trade: 4.78 0.03 0.63

PDUFA target action date is May 25, 2024  FDA does not currently plan to hold Advisory Committee meeting for pz-cel BLA  CLEVELAND, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel), Abeona’s investigational...Read more


Autolus Therapeutics Submits Biologics License Application to U.S. Food and Drug Administration for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (ALL)

November 27
Last Trade: 4.36 0.28 6.86

BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) Company on track to submit a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024 LONDON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing...Read more


Bristol Myers Squibb and 2seventy bio Provide Update on U.S. FDA Review of sBLA for Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma

November 20
Last Trade: 50.31 0.15 0.30

PRINCETON, N.J. & CAMBRIDGE, Mass. / Nov 20, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory...Read more


U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

November 9
Last Trade: 50.31 0.15 0.30

Application based on results from TRANSCEND CLL 004, the first pivotal multicenter trial to show clinical benefit with a CAR T cell therapy in heavily pre-treated patients with relapsed or refractory CLL or SLL, in which Breyanzi demonstrated deep and durable efficacy U.S. Food and Drug Administration (FDA) has assigned a target action date of March 14, 2024 If approved, Breyanzi would be the first and only CAR T cell therapy available...Read more


Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira®

November 7
Last Trade: 11.02 -0.31 -2.74

sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued group Filing acceptance reinforces Samsung Bioepis and Organon’s commitment to provide better access to biologic medicines for patients in the United States INCHEON, South Korea and JERSEY CITY, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) --...Read more


FDA Accepts ImmunityBio’s BLA Resubmission as Complete and Sets New PDUFA Date

October 26
Last Trade: 3.43 -0.03 -0.87

BLA for N-803 plus BCG in high-risk non-muscle-invasive bladder cancer (NMIBC) was resubmitted to the Agency on October 23, 2023 A new PDUFA date of April 23, 2024 has been communicated by the Agency CULVER CITY, Calif. / Oct 26, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio’s...Read more


US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal)

October 24
Last Trade: 63.25 -0.26 -0.41

Potential to be the first and only self-administered flu vaccine WILMINGTON, Del. / Oct 24, 2023 / Business Wire / AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal), a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA). If approved, FLUMIST QUADRIVALENT...Read more


ImmunityBio Announces Biological License Application Resubmission for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma-In-Situ

October 23
Last Trade: 3.43 -0.03 -0.87

Provides updated data on prolonged duration of complete response in BCG-Unresponsive and BCG-Naïve NMIBC patients Following the Type A Meeting with the FDA, ImmunityBio has completed the BLA resubmission addressing the issues in the Complete Response Letter. As part of this resubmission, ImmunityBio provided an update on the Duration of Complete Response (CR) in BCG-unresponsive NMIBC patients with CIS ± Ta/T1 disease (QUILT-3.032)...Read more


Regeneron Pharmaceuticals and Sanofi Provide Update on Dupixent® (dupilumab) sBLA for Chronic Spontaneous Urticaria

October 20
Last Trade: 840.14 -9.04 -1.06

TARRYTOWN, N.Y. and PARIS, Oct. 20, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in chronic spontaneous urticaria (CSU). CSU is an inflammatory skin condition, which causes sudden and debilitating hives and...Read more


Alvotech Provides Update on Status of U.S. Biologics License Application for AVT04

October 12
Last Trade: 9.17 -0.34 -3.58

REYKJAVIK, Iceland, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara® (ustekinumab). As expected, the CRL...Read more


Coherus BioSciences Announces Resubmission of Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™

October 5
Last Trade: 2.22 -0.08 -3.48

Resubmission follows the satisfactory resolution of the FDA’s review of inspection findings at the third-party filler  REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced the Company has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, the company's on-body injector presentation of UDENYCA® (pegfilgrastim-cbqv), to the...Read more


Eli Lilly: U.S. Food and Drug Administration Issues Complete Response Letter for Lebrikizumab Based on Inspection Findings at Third-Party Manufacturer

October 2
Last Trade: 598.05 9.78 1.66

In the letter, the FDA stated no concerns about the clinical data package, safety or label for lebrikizumab INDIANAPOLIS, Oct. 2, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema). The letter cited findings...Read more


Rocket Pharmaceuticals Announces FDA Acceptance of Biologics License Application with Priority Review for RP-L201 (marnetegragene autotemcel) for the Treatment of Severe Leukocyte Adhesion Deficiency-I (LAD-I)

October 2
Last Trade: 25.23 -1.07 -4.07

Prescription Drug User Fee Act (PDUFA) target action date is March 31, 2024 RP-L201 has received FDA Regenerative Medicine Advanced Therapy (RMAT), Rare Pediatric, Fast Track and Orphan Drug designations; Rocket eligible for Priority Review Voucher, if RP-L201 is approved CRANBURY, N.J. / Oct 02, 2023 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and...Read more


Regeneron Pharmaceuticals: Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review

September 29
Last Trade: 840.14 -9.04 -1.06

If approved, odronextamab would be the first and only bispecific antibody approved in both FL and DLBCL – the two most common subtypes of non-Hodgkin lymphoma European Medicines Agency also reviewing odronextamab Marketing Authorization Application TARRYTOWN, N.Y., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for...Read more


Capricor Therapeutics Announces Positive Type-B Meeting with the FDA to Discuss Pathway to BLA for CAP-1002 in Duchenne Muscular Dystrophy

September 29
Last Trade: 3.69 0.27 7.89

FDA Feedback on the Proposed Key Clinical and Regulatory Requirements Confirms CAP-1002’s Path Towards a Biologics License Application (BLA) Company On Track to Complete HOPE-3 Enrollment and Report Outcome from Interim Analysis in Q4 2023 Conference Call and Webcast Today at 8:30 a.m. ET SAN DIEGO, Sept. 29, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of...Read more


Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH)

September 28
Last Trade: 103.75 -0.13 -0.13

Application based on clinically meaningful results from the Phase 3 STELLAR trial If approved, sotatercept would be the first in its class, bringing a novel approach to address a rare and progressive disease of the pulmonary arteries RAHWAY, N.J. / Sep 28, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for...Read more


BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS

September 27
Last Trade: 0.20 -0.02 -9.77

NEW YORK, Sept. 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the outcome of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application (BLA) for NurOwn®, an investigational mesenchymal stem cell therapy for the...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) sBLA for Treatment of Eosinophilic Esophagitis (EoE) in Children Aged 1 to 11 Accepted for FDA Priority Review

September 26
Last Trade: 840.14 -9.04 -1.06

If approved, Dupixent would be the first and only treatment in the U.S. indicated for children aged 1 to 11 with EoE, a disease driven by type 2 inflammation that impacts the ability to eat Of the approximately 21,000 children under the age of 12 in the U.S. currently being treated for EoE, about 9,000 do not satisfactorily respond to the unapproved therapies they have been treated with and potentially require advanced alternative...Read more


Abeona Therapeutics Submits Biologics License Application to U.S. FDA Seeking Priority Review and Approval of EB-101 for the Treatment of Patients with Recessive Dystrophic Epidermolysis Bullosa

September 26
Last Trade: 4.78 0.03 0.63

CLEVELAND, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of EB-101, its investigational autologous, engineered cell therapy, as a treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB). As part of the submission, Abeona requested a Priority...Read more


Theratechnologies Submits Tesamorelin F8 Formulation sBLA for FDA Review

September 25
Last Trade: 1.60 0.02 0.95

F8 formulation intended to replace EGRIFTA SV® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has filed a...Read more


FDA Issues Complete Response Letter (CRL) for UDENYCA® ONBODY™ Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus BioSciences Also Announces Completion of Toripalimab FDA Inspections

September 25
Last Trade: 2.22 -0.08 -3.48

 No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were identified in the UDENYCA® ONBODY™ CRL  No additional UDENYCA® ONBODY™ clinical data or trials have been requested by the FDA  Toripalimab inspections completed  REDWOOD CITY, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS),...Read more


FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Concurrent Chemoradiotherapy as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

September 20
Last Trade: 103.75 -0.13 -0.13

Acceptance based on results from the Phase 3 KEYNOTE-A18 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival in these patients RAHWAY, N.J. / Sep 20, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License...Read more


Alvotech Provides U.S. Regulatory Update on AVT02, a High-Concentration Interchangeable Biosimilar Candidate to Humira® (adalimumab)

September 20
Last Trade: 9.17 -0.34 -3.58

REYKJAVIK, Iceland, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar candidate to Humira®...Read more


BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®

September 19
Last Trade: 175.00 -4.36 -2.43

European Commission approves TEVIMBRA for previously treated advanced or metastatic esophageal squamous cell carcinoma (ESCC) U.S. FDA accepts Biologics License Application in first-line advanced ESCC BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Sep 19, 2023 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the European Commission (EC) has...Read more


Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review

September 18
Last Trade: 16.27 -0.01 -0.06

PDUFA date set for March 18, 2024 OTL-200 would be the first and only treatment in the U.S. for early-onset MLD Previously published data demonstrated administration of one-time gene therapy enables sustained preservation of motor function and cognitive development BOSTON and LONDON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug...Read more


Iovance Biotherapeutics: U.S. Food and Drug Administration Updates Prescription Drug User Fee Act (PDUFA) Action Date for Lifileucel for the Treatment of Advanced Melanoma

September 14
Last Trade: 6.40 -0.33 -4.90

Priority Review Continues with Successful Facility Inspections Completed,no Major Review Issues FDA Extends PDUFA Date to February 24, 2024 on Resource Constraints and Agrees to Work with Iovance to Expedite Remaining Review SAN CARLOS, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating...Read more


Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

September 13
Last Trade: 14.06 -0.02 -0.14

Applications for Investigational Subcutaneous Administrations for Both Crohn’s Disease and Ulcerative Colitis Are Now Under Review by the FDA OSAKA, Japan & CAMBRIDGE, Mass. / Sep 13, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous (SC) administration of ENTYVIO®...Read more


Roche: FDA Accepts Application for Genentech’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition

September 6
Last Trade: 36.00 0.42 1.18

Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal hemoglobinuria (PNH) If approved, crovalimab will be the first monthly subcutaneous treatment for PNH, with the option to self-administer outside of a supervised healthcare setting Filing applications have also been accepted in the EU, China and Japan, and submissions to...Read more


Mesoblast Receives Complete Response From U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children

NEW YORK, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the US Food and Drug Administration (FDA) has provided a complete response to its Biologics License Application (BLA) resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD) and requires more...Read more


Orchard Therapeutics Completes Submission of Biologics License Application for OTL-200 in MLD to U.S. FDA

August 3
Last Trade: 16.27 -0.01 -0.06

Reported $6.6M in Q2’23 Libmeldy net sales, representing the highest quarter to date $34.0M of additional capital from second closing of strategic financing extends runway to mid-2025 Four MLD patients identified from ~150,000 newborns screened in prospective studies suggests significantly higher incidence than previously estimated in the medical literature Six presentations at ASGCT demonstrate the ability of HSC gene therapy to...Read more


Abeona Therapeutics Announces Submission of Briefing Package for Pre-Biologics License Application (BLA) Meeting with FDA in August 2023

CLEVELAND, July 28, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has completed the submission of the briefing package to the U.S. Food and Drug Administration (FDA) for the Company’s pre-Biologics License Application (BLA) meeting in August 2023. The purpose of the pre-BLA meeting is to discuss with the FDA the format, content, and acceptability of the anticipated BLA for EB-101, Abeona’s...Read more


Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA

July 12
Last Trade: 68.86 -0.89 -1.28

In January 2023, the company had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate DRL_RI, with the intention to file in the United States, European Union and other regions Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review HYDERABAD, India / Jul 12, 2023 / Business Wire / Dr. Reddy’s Laboratories Ltd....Read more


Alvotech Provides Regulatory Update on Second Biologics License Application for AVT02

REYKJAVIK, Iceland, June 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira®...Read more


Regeneron Pharmaceuticals: FDA Issues Complete Response Letter (CRL) for Aflibercept 8 mg Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-party Filler

June 27
Last Trade: 840.14 -9.04 -1.06

No issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL No additional clinical data or trials have been requested TARRYTOWN, N.Y., June 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA)...Read more


FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec

June 27
Last Trade: 28.78 0.15 0.52

Regulatory application also under review with EMA Submissions based on positive Phase 3 data from BENEGENE-2 trial NEW YORK / Jun 27, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization...Read more


bluebird bio Announces FDA Priority Review of the Biologics License Application for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events

BLA submission based on data from the largest and most mature clinical development program for any gene therapy in sickle cell disease PDUFA date set for December 20, 2023 SOMERVILLE, Mass. / Jun 21, 2023 / Business Wire / bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review....Read more


FDA Accepts for Review Medexus's IXINITY Supplemental Biological License Application for Pediatric Patients

Expanded indication would cover patients 12 years of age or younger, a population that comprises approximately one in three patients treated for hemophilia B in the United States Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - June 15, 2023) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently accepted for review Medexus's supplemental Biological License...Read more


Abeona Therapeutics Announces Regulatory Update on Biologics License Application (BLA) for EB-101

CLEVELAND, June 09, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received feedback from the U.S. Food and Drug Administration (FDA) on June 8, 2023, in which the Company gained the Agency’s alignment on the data required to establish retroviral vector (RVV) comparability, a critical Chemistry, Manufacturing and Controls (CMC) component for the EB-101 Biologics License Application...Read more


Vertex Pharmaceuticals: FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

June 8
Last Trade: 350.15 -3.80 -1.07

First CRISPR gene-editing filings to be accepted for review by FDA FDA grants Priority Review for severe sickle cell disease (SCD) and Standard Review for transfusion-dependent beta thalassemia (TDT) PDUFA target action date of December 8, 2023, for SCD and March 30, 2024, for TDT BOSTON & ZUG, Switzerland / Jun 08, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP)...Read more


FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer

June 8
Last Trade: 103.75 -0.13 -0.13

Acceptance based on results from the Phase 3 KEYNOTE-966 trial, which showed a significant overall survival benefit in these patients RAHWAY, N.J. / Jun 08, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s...Read more


Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel)

The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival compared to standard regimens CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy and safety of cell therapy as early as after first relapse in multiple myeloma SOMERSET, N.J. / Jun 06, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend...Read more


BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review NurOwn® Biologics License Application Scheduled for September 27, 2023

PDUFA target action date set to occur by December 8, 2023 NEW YORK, June 6, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) will convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (ADCOM) to review the Biologics...Read more


Iovance Biotherapeutics Announces U.S. Food and Drug Administration Acceptance of the Biologics License Application of Lifileucel for the Treatment of Advanced Melanoma

Priority Review Granted with Prescription Drug User Fee Act (PDUFA) Action Date of November 25, 2023 First Potential Approval of an Individualized, One-Time Cell Therapy for Patients with Advanced Melanoma SAN CARLOS, Calif., May 26, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte...Read more


Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001

New regulatory action date is June 22, 2023 CAMBRIDGE, Mass. / May 24, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who...Read more


U.S. Food & Drug Administration Grants Priority Review of TAK-755 for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

May 16
Last Trade: 14.06 -0.02 -0.14

Submission Based on Favorable Results from the First Phase 3 Randomized, Controlled Trial in Patients with cTTP FDA has Granted TAK-755 Priority Review and Rare Pediatric Disease Designation, as well as Fast Track Designation and Orphan Drug Designation in cTTP OSAKA, Japan & CAMBRIDGE, Mass. / May 16, 2023 / Business Wire / Takeda (TSE: 4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted...Read more


FDA Accepts Application for Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

May 9
Last Trade: 36.00 0.42 1.18

Acceptance based on two Phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to aflibercept Application was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid If approved, RVO would be the third indication for Vabysmo in addition to wet age-related macular degeneration (AMD) and diabetic macular edema...Read more


Bristol Myers Squibb: U.S. FDA Accepts for Priority Review Supplemental Biologics License Application and EMA Validates Application for Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic...

May 1
Last Trade: 50.31 0.15 0.30

Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically significant and clinically meaningful improvement compared to an erythropoiesis-stimulating agent in patients with very low/low/intermediate-risk MDS U.S. FDA has assigned a target action date of August 28, 2023 PRINCETON, N.J. / May 01, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced...Read more


Takeda Announces FDA Acceptance of BLA Resubmission for Investigational Subcutaneous Administration of Entyvio® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis

April 27
Last Trade: 14.06 -0.02 -0.14

OSAKA, Japan & CAMBRIDGE, Mass. / Apr 27, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) resubmission for the investigational subcutaneous (SC) administration of Entyvio® (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction...Read more


bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events

April 24
Last Trade: 2.86 -1.95 -40.54

BLA submission based on data from the largest and most mature clinical development program for any gene therapy in sickle cell disease SOMERVILLE, Mass. / Apr 24, 2023 / Business Wire / bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD)...Read more


Bristol Myers Squibb and 2seventy bio: Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed Relapsed and/or Refractory Multiple Myeloma

April 17
Last Trade: 50.31 0.15 0.30

U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023 European Medicines Agency has validated Bristol Myers Squibb’s Type II variation application for Abecma Bristol Myers Squibb’s supplemental New Drug Application for Abecma has also been accepted by Japan's Ministry of Health, Labour and Welfare Applications based on interim...Read more


Alvotech Provides Regulatory Update on AVT02 Biologics License Application

REYKJAVIK, Iceland, April 14, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab)....Read more


FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

April 13
Last Trade: 103.75 -0.13 -0.13

Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression RAHWAY, N.J. / Apr 13, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License...Read more


Takeda Receives FDA Approval to Expand the Use of HYQVIA® to Treat Primary Immunodeficiency in Children

April 11
Last Trade: 14.06 -0.02 -0.14

HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the Only Once-a-Month – Every Three or Four Weeks – Subcutaneous Immunoglobulin (ScIG), is Now Approved for People Two Years of Age and Older with Primary Immunodeficiency Approval Supported by Pivotal Phase 3 Study that Demonstrated Reliable Infection Protection in Children 2-16 Years Old CAMBRIDGE, Mass. / Apr 11, 2023 / Business Wire / Takeda...Read more


Vertex Pharmaceuticals and CRISPR Therapeutics Complete Submission of Rolling Biologics License Applications (BLAs) to the US FDA for exa-cel for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

April 3
Last Trade: 350.15 -3.80 -1.07

EU and UK filings completed in 2022; submissions validated by EMA and MHRA and the review procedure has begun as of January 2023 BOSTON & ZUG, Switzerland / Apr 03, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced the completion of the rolling Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for the investigational...Read more


BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn® for the Treatment of ALS

Conference call and webcast at 8:00 a.m. ET NEW YORK, March 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting ('ADCOM') to discuss the company's Biologics License Application (BLA) for NurOwn® for the treatment of...Read more


Iovance Biotherapeutics Completes Biologics License Application (BLA) Submission for Lifileucel in Advanced Melanoma

SAN CARLOS, Calif., March 24, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel. Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients...Read more


Regeneron Pharmaceuticals: FDA Approves First-in-class Evkeeza® (evinacumab-dgnb) for Young Children with Ultra-rare Form of High Cholesterol

March 22
Last Trade: 840.14 -9.04 -1.06

Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH), an inherited condition characterized by extremely high low-density lipoprotein cholesterol (LDL-C) 48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other lipid-lowering therapies in the pivotal trial TARRYTOWN, N.Y., March 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today...Read more


FDA Accepts Mesoblast’s Resubmission of the Biologic License Application for Remestemcel-L In Children with Steroid-Refractory Acute Graft Versus Host Disease as a Complete Response and Sets Goal Date of August 2, 2023

NEW YORK, March 07, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) has accepted the Company’s Biologics License Application (BLA) resubmission for remestemcel-L in the treatment of children with steroid-refractory acute graft versus...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) Application for Treatment of Chronic Spontaneous Urticaria (CSU) in Adults and Adolescents Aged 12 Years and Older Accepted for FDA Review

March 7
Last Trade: 840.14 -9.04 -1.06

TARRYTOWN, N.Y. and PARIS, March 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current...Read more


Biogen: FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

March 5
Last Trade: 239.29 0.17 0.07

Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review time with a Prescription Drug User Fee Act (PDUFA) target action on July 6, 2023 TOKYO and CAMBRIDGE, Mass., March 05, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB,...Read more


Checkpoint Therapeutics Announces FDA Filing Acceptance of Biologics License Application for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024 FDA indicates that it does not currently plan to hold an advisory committee meeting WALTHAM, Mass., March 02, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing the Biologics...Read more


U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab) ….

February 28
Last Trade: 50.31 0.15 0.30

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab) as an Adjuvant Treatment for Patients with Completely Resected Stage IIB or IIC Melanoma PRINCETON, N.J. / Feb 28, 2023 / Business Wire /  Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted...Read more


U.S. FDA Accepts Biologics License Application for Pfizer’s Respiratory Syncytial Virus Maternal Vaccine Candidate for Priority Review

February 21
Last Trade: 28.78 0.15 0.52

NEW YORK / Feb 21, 2023 / Business Wire / Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate PF-06928316 or RSVpreF for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age by...Read more


ADMA BioCenters Receives FDA Approval for its Eighth Plasma Collection Center, Located in Hammond, LA

February 8
Last Trade: 3.71 -0.06 -1.59

FDA Approval Supports Corporate Goal of Plasma Supply Self-Sufficiency and Ongoing Revenue Growth Company Remains On-Track to Have All 10 Plasma Collection Centers FDA-Licensed by Year-End 2023 RAMSEY, N.J. and BOCA RATON, Fla. and HAMMOND, La., Feb. 08, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and...Read more


Mesoblast Resubmits Biologic License Application (BLA) to FDA for Remestemcel-L in Children With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)

January 31
Last Trade: 1.02 -0.08 -7.27

Validation of Remestemcel-L Potency Assay used in the Phase 3 Trial which Measures In-Vivo Activity based on Mechanism of Action Assay Identifies High-Potency Product Lots Associated with Enhanced Survival New Data Show that Remestemcel-L Improves Inflammatory Biomarkers and Survival in Children at Highest Risk of Mortality New 4-Year Data from the Phase 3 Trial Shows Durable Long-Term Survival Outcomes BLA Resubmission will have a...Read more


Krystal Biotech Announces FDA’s 3-Month Extension of BLA PDUFA Date and Regulatory Update for B-VEC to Treat Patients with Dystrophic Epidermolysis Bullosa

January 9
Last Trade: 106.86 3.46 3.35

PITTSBURGH, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that on January 5, 2023, the U.S. Food and Drug Administration (FDA) notified the Company that based on manufacturing information submitted to the Agency on December 20, 2022, in response to an information request, the PDUFA date has been revised to May 19, 2023, and proposed labeling discussions to no later than...Read more


Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer's Disease

January 6
Last Trade: 239.29 0.17 0.07

Submission for traditional approval follows FDA accelerated approval of LEQEMBI on the same day, and is based on data from the confirmatory Phase 3 Clarity AD clinical trial TOKYO and CAMBRIDGE, Mass., Jan. 6, 2023 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher "Biogen") announced Eisai...Read more


Revance Therapeutics Announces U.S. FDA Acceptance of Supplemental Biologics License Application (sBLA) for DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia

Prescription Drug User Fee Act (PDUFA) date of August 19, 2023 Revance Therapeutics, Inc. (Nasdaq: RVNC) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults, a chronic and debilitating neurologic condition affecting the muscles of the neck.1...Read more


Pfizer: U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine in Infants and Children

January 6
Last Trade: 28.78 0.15 0.52

If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants and children, and have the potential to help protect against more of the clinically significant remaining burden of disease Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for its 20-valent...Read more


Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)

January 6
Last Trade: 9.17 -0.34 -3.58

The U.S. Food and Drug Administration’s (FDA) regulatory review is anticipated to be completed in the second half of 2023 Stelara® (ustekinumab) is prescribed to treat a variety of inflammatory conditions REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva...Read more


Checkpoint Therapeutics Submits Biologics License Application to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

WALTHAM, Mass., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the submission of a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for the approval of cosibelimab, its investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell...Read more


Pfizer: U.S. FDA Accepts for Review the Biologics License Application for Pfizer’s Investigational Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents

December 28
Last Trade: 28.78 0.15 0.52

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine candidate (MenABCWY). Pfizer submitted MenABCWY for the prevention of...Read more


Coherus BioSciences and Junshi Biosciences Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

December 24
Last Trade: 2.22 -0.08 -3.48

FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA Coherus and Junshi Biosciences are actively engaged in ongoing discussions with the FDA to support the inspections and gain approval of toripalimab for patients with NPC in the U.S. as quickly as possible - SHANGHAI, China, and REDWOOD CITY, Calif., Dec. 24, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co.,...Read more


Adaptimmune Therapeutics Announces Initiation of Biologics License Application (BLA) Submission for Afami-cel, Its First-Gen Engineered TCR T-cell Therapy targeting MAGE-A4, For the Treatment of Synovial Sarcoma

December 23
Last Trade: 0.54 -0.03 -4.39

Afami-cel has the potential to be the first approved engineered TCR T-cell therapy for a solid tumor ynovial sarcoma has a high unmet medical need and the pivotal trial met its primary endpoint with an overall response rate of ~39% after a single dose of afami-cel Adaptimmune plans to complete its rolling BLA submission for afami-cel in mid-2023; and with RMAT status for synovial sarcoma, the application will be eligible for priority...Read more


Seagen Announces FDA Acceptance of Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

December 20
Last Trade: 218.98 0.65 0.30

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting FDA granted the applications Priority Review with a PDUFA date of April 21, 2023 TOKYO, BOTHELL, Wash. and RAHWAY, N.J., Dec. 20, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), Seagen Inc. (Nasdaq: SGEN) and Merck...Read more


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