Company Aligned with FDA on Demonstration of Non-Clinical Comparability; Allowing for Immediate Use of San Diego Manufacturing Facility FDA Feedback Supports Requests for a Pre-BLA Meeting and Subsequent Rolling BLA Submission Following Upcoming Q2 Type-B FDA Meeting Company Granted Subsequent Type-B Clinical Meeting with FDA in Second Quarter to Continue to Discuss Pathway to BLA Capricor Management to Host Virtual Investor Webcast...Read more
Submission based on data from Phase 2b HERIZON-BTC-01 trial, which met its primary endpoint in patients receiving zanidatamab for previously treated HER2-positive biliary tract cancer (BTC) Confirmatory Phase 3 trial in first-line (1L) BTC open for enrollment at multiple global sites DUBLIN, April 2, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has completed the rolling...Read more
Application based on results from the TROPION-Breast01 phase 3 trial Additional BLA under review in the U.S. for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan for patients with advanced nonsquamous non-small cell lung cancer TOKYO & BASKING RIDGE, N.J. / Apr 02, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan...Read more
TOKYO and CAMBRIDGE, Mass., March 31, 2024 /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 today that Eisai submitted to the U.S. Food and Drug Administration (FDA) a Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®)...Read more
Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and efficacy in previously treated patients in this age group Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - March 26, 2024) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus's supplemental Biologics License Application (sBLA)...Read more
NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for...Read more
TARRYTOWN, N.Y., March 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. The only...Read more
SOLANA BEACH, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today congratulates its partner PTC Therapeutics on completion of its BLA submission to the U.S. Food and Drug Administration (FDA) for the approval of Upstaza™ (eladocagene exuparvovec), an investigational treatment for...Read more
FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2024 CRANFORD, N.J., March 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of...Read more
FDA Approval Provides for Room Temperature (25°C) Storage Conditions for up to 4 Weeks at Any Point During the 36-Month Approved Shelf Life Extends the Prior Room Temperature Storage Allowance for the Full 36-months for ASCENIV and BIVIGAM Provides for Improved Inventory Management and Ease of Product Administration to Patients Approval of Extended Ambient Storage Conditions for ASCENIV & BIVIGAM is Immediately Effective and Now...Read more
Priority Review acceptance based on positive results of AGAVE-201 study WILMINGTON, Del. / Feb 27, 2024 / Business Wire / Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic...Read more
A supplementary Biologics License Application (sBLA) is supported by data from the Phase 1/2 EPCORE™ NHL-1 clinical trial in patients with relapsed or refractory (R/R) follicular lymphoma (FL), demonstrating strong and durable treatment responses In November 2023, the FDA granted this investigational indication a Breakthrough Therapy Designation (BTD) NORTH CHICAGO, Ill., Feb. 27, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today...Read more
FDA grants Priority Review with target action date of June 28, 2024 Application based on results from Phase 1/2 EPCORE™ NHL-1 trial demonstrating clinically meaningful treatment responses in difficult-to-treat patients with relapsed or refractory (R/R) follicular lymphoma (FL) sBLA submission demonstrates Genmab’s commitment to exploring potential utility of epcoritamab across B-cell malignancies COPENHAGEN, Denmark / Feb 27, 2024 /...Read more
Application based on results from global Phase 3 RATIONALE-305 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival in advanced gastric/GEJ cancer Prescription Drug User Fee Act target action date set for December 2024 BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Feb 27, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today...Read more
TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. The target action date for the FDA...Read more
Biweekly dosing with TECVAYLI®, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W)...Read more
Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2024 If approved, VYVGART® Hytrulo will be the first neonatal Fc receptor (FcRn) blocker to treat CIDP February 20, 2024, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and...Read more
Application based on results from the TROPION-Lung01 Phase III trial If approved, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan may be the first TROP2-directed antibody drug conjugate for patients with lung cancer WILMINGTON, Del. / Feb 19, 2024 / Business Wire / AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult...Read more
Priority review granted, with a review goal date of June 21, 2024 CAMBRIDGE, Mass. / Feb 16, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's efficacy supplement to the Biologics License Application (BLA) for ELEVIDYS (delandistrogene moxeparvovec-rokl) (the...Read more
FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act (PDUFA) date is expected within 30 days of resubmission CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced the...Read more
New Prescription Drug User Fee Act (PDUFA) date of June 30, 2024 CRANBURY, N.J. / Feb 13, 2024 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced the U.S. Food and Drug Administration (FDA) has extended the Priority Review period for the Biologics License...Read more
BLA submission supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a Humanitarian Aid Program to treat wartime trauma injuries in Ukraine The HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks PDUFA date set for August 10, 2024 DURHAM, N.C., Feb. 09, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a...Read more
Applications based on results from CheckMate -77T, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of non-metastatic non-small cell lung cancer The perioperative Opdivo-based regimen demonstrated significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo The U.S. Food and Drug Administration...Read more
Application supported by positive results of a phase III trial showing immune response and acceptable tolerability profile in this population Adults aged 50 and above with underlying medical conditions are at increased risk for RSV disease1,2,3 GSK is the first company to file for regulatory approval to extend RSV vaccination to adults aged 50-59 at increased risk US FDA has set a Prescription Drug User Fee Act action date of June 7,...Read more
PRINCETON, N.J., & CAMBRIDGE, Mass. / Feb 05, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that a notice was published in the Federal Register that the U.S. Food and Drug Administration (FDA) will convene a virtual meeting of the Oncologic Drugs Advisory Committee (ODAC) on March 15, 2024, to review data supporting the supplemental Biologics License Application (sBLA) for...Read more
On track for PDUFA target action date of May 25, 2024 CLEVELAND, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced, as part of the review process by the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB), completion by the FDA of both a Bioresearch Monitoring (BIMO)...Read more
If approved, afami-cel will be the first engineered T-cell therapy for solid tumors and the first effective treatment option for synovial sarcoma in more than a decade Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - January 31, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced that the U.S. Food and Drug...Read more
If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU will potentially be the first HER2-directed treatment and antibody drug conjugate to receive a tumor-agnostic indication Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU data Submission to be reviewed under FDA Real-Time Oncology Review and Project Orbis WILMINGTON, Del. / Jan 29, 2024 / Business Wire / AstraZeneca and Daiichi Sankyo's...Read more
FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity CRL does not impact commercial availability of EGRIFTA SV®, the F4 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or...Read more
FDA continues to review the file past the Prescription Drug User Fee Act goal date of January 22, 2024 MONTREAL, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s...Read more
PDUFA Goal date is November 16, 2024 Company on track to submit a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024 LONDON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the U.S. Food and Drug Administration (FDA) has accepted its...Read more
REYKJAVIK, Iceland, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech’s facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one...Read more
If approved, NexoBrid will serve as an effective non-surgical treatment for both pediatric and adult burn patients in the U.S. NexoBrid is already approved for use for burn patients across all age groups in Europe and Japan YAVNE, Israel, Jan. 09, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced...Read more
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy NEW YORK & COPENHAGEN, Denmark / Jan 09, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of...Read more
Trogarzo® IM maintenance dosing aims to further enhance the convenience of non-oral therapy for heavily treatment-experienced adults with HIV Submission comes on the heels of the recent FDA approval of the Trogarzo® IV push loading dose MONTREAL, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development...Read more
Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients with advanced EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies Application being evaluated under FDA Real-Time Oncology Review If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these...Read more
Application includes request for Priority Review from the US FDA Sarepta has also submitted the EMBARK postmarketing requirement to the FDA seeking conversion of the ELEVIDYS accelerated approval to traditional approval CAMBRIDGE, Mass. / Dec 22, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced submission of an efficacy supplement to the...Read more
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure Interim analysis results from first-of-its-kind Phase III OUtMATCH study showed Xolair significantly increased the amount of peanut, milk, egg and cashew it took to cause an allergic reaction 17 million people in the U.S. have confirmed food allergies and more than 40% of children and more than half of adults...Read more
Acceptance based on results from multiple Phase 3 trials If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults The 21 serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 and older, according to CDC data from 2018-2021 RAHWAY, N.J. / Dec 19, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States...Read more
WALTHAM, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for the cosibelimab biologic license application (“BLA”) for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or...Read more
Currently There are no Approved Therapeutic Options for Third-Line Treatment of Advanced SCLC1 If Approved, Tarlatamab Would be the First BiTE® Therapy for a Major Solid Tumor FDA Target Action Date is June 12, 2024 THOUSAND OAKS, Calif., Dec. 13, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License...Read more
BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a humanitarian aid program to treat wartime trauma injuries in Ukraine The HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks DURHAM, N.C., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform...Read more
Signifies the Successful Fulfillment of BIVIGAM’s Post Marketing Commitments as Part of the Original BLA Approval Expanded Label in the U.S. Now Includes Pediatric PI Patients 2 Years of Age and Older RAMSEY, N.J. and BOCA RATON, Fla., Dec. 12, 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
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting If approved in the U.S. and EU, marstacimab could become the first once-weekly subcutaneous treatment for people living with hemophilia B and the first treatment administered as a flat dose for people living with hemophilia A or B NEW YORK / Dec 11, 2023 / Business Wire /...Read more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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