NOVATO, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA or the Agency) seeking accelerated approval for UX111 (ABO-102) AAV gene therapy as a treatment for patients with Sanfilippo syndrome type A (MPS IIIA). “The path to get a treatment to the point of a BLA filing has been long...Read more
Company Expects to Complete BLA Submission by End of 1Q 2025 LANGHORNE, Pa. / Dec 18, 2024 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, initiated a rolling submission of a BLA to the FDA for MOLBREEVI for the potential treatment of aPAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant...Read more
If approved, clesrovimab has the potential to be available to help address the burden of RSV disease in the U.S. in time for the 2025-26 season RAHWAY, N.J. / Dec 17, 2024 / 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 the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational...Read more
COPENHAGEN, Denmark, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) in adult growth hormone deficiency (GHD) for TransCon hGH (lonapegsomatropin-tcgd; marketed as SKYTROFA® for pediatric GHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 27,...Read more
Decision based on NIAGARA Phase III trial results which demonstrated a statistically significant and clinically meaningful event-free and overall survival benefit If approved, this will be the first and only perioperative immunotherapy regimen in this curative-intent setting WILMINGTON, Del. / Dec 06, 2024 / Business Wire / AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) has been accepted and...Read more
Application is based on data from the Phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progression Improving survival outcomes is needed for...Read more
Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis SPRING HOUSE, Pa., Dec. 2, 2024 /PRNewswire/ -- Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of children 6 years and older...Read more
Resubmission addresses questions raised in January 2024 Complete Response Letter F8 formulation intended to replace EGRIFTA SV® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and...Read more
Following recent U.S. FDA approval of TREMFYA® for adults with moderately to severely active ulcerative colitis (UC), this submission underscores its potential to be the only IL-23 inhibitor that offers choice of subcutaneous or intravenous induction in UC Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to...Read more
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:...Read more
CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona’s resubmission of its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), its investigational autologous cell-based gene therapy, as a potential new treatment for recessive dystrophic epidermolysis bullosa (RDEB). The FDA has assigned a...Read more
SHANGHAI, China & JERSEY CITY, N.J. / Oct 30, 2024 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). Denosumab has been approved in various countries and regions under different trade names for a range of different indications,...Read more
CLEVELAND, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Company has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA or Agency) for prademagene zamikeracel (pz-cel), its investigational autologous cell-based gene therapy, as a potential new treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB). “We have worked...Read more
Company Plans to Complete Rolling BLA Submission by End of 2024; Application May be Eligible for Priority Review by FDA SAN DIEGO, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today that it has initiated its rolling submission process with the U.S. Food and Drug Administration...Read more
Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory...Read more
Based on DESTINY-Breast06 Phase III trial which demonstrated a statistically significant and clinically meaningful progression-free survival benefit for ENHERTU If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU will be the first HER2 directed therapy and ADC for patients prior to receiving chemotherapy for metastatic breast cancer ENHERTU also granted Breakthrough Therapy Designation in the US for this patient...Read more
Results from CEPHEUS study highlight DARZALEX FASPRO® quadruplet regimen as a potential standard of care in newly diagnosed patients regardless of transplant eligibility New indication would be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on a study with MRD-negativity as the primary endpoint RARITAN, N.J., Sept. 30, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the...Read more
COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH (marketed as SKYTROFA® (lonapegsomatropin-tcgd) in the U.S. for pediatric growth hormone deficiency) for the treatment of adults with growth hormone deficiency (GHD). “The sBLA submission for...Read more
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. Biologics License Application (BLA) submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial (M14-239). Review of the BLA will be conducted under FDA's Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR)...Read more
ALACHUA, Fla. and TAMPA, Fla., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®. “I am proud of the significant progress our team has made...Read more
GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection....Read more
Marks first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies Filing based on the Phase 3 Vivacity-MG3 program, the first-and-only study results in the class demonstrating sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ SPRING HOUSE, Pa., Aug. 29, 2024...Read more
First Restorative Biologic Cartilage Repair Product Approved for Arthroscopic Administration Targets the Largest Segment of MACI’s $3 Billion Addressable Market CAMBRIDGE, Mass., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics...Read more
Acceptance based on Phase 3 CheckMate -9DW trial results demonstrating improved survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of lenvatinib or sorafenib in this patient population The U.S. Food and Drug Administration assigned a target action date of April 21, 2025 PRINCETON, N.J. / Aug 21, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug...Read more
TARRYTOWN, N.Y., Aug. 20, 2024 (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) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. This anticipated outcome was previously disclosed during...Read more
Based on ADRIATIC Phase III trial which demonstrated statistically significant and clinically meaningful overall survival and progression-free survival benefit WILMINGTON, Del. / Aug 15, 2024 / Business Wire / AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab), based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer (LS-SCLC) whose...Read more
WALTHAM, Mass., July 25, 2024 (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 review Checkpoint’s resubmission of its Biologics License Application (“BLA”) for cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, as a potential new treatment for...Read more
Now Approved for Children of All Ages with CLN2 Batten Disease, Regardless of Whether They Yet Show Symptoms SAN RAFAEL, Calif., July 24, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for BRINEURA® (cerliponase alfa) to slow the loss of ambulation in children of all ages with...Read more
NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that the United States Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) resubmission for Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). FDA considers the...Read more
Prescription Drug User Fee Act (PDUFA) Target Action Date of January 15, 2025 If Approved, Tab-cel Would Be First Approved Therapy in U.S. for EBV+ PTLD BLA Acceptance Triggers $20 Million Milestone Payment from Pierre Fabre Laboratories, with Additional $60 Million Milestone if Approved by FDA THOUSAND OAKS, Calif. / Jul 17, 2024 / Business Wire / Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy,...Read more
Bagsværd, Denmark, 10 July 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus. In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed....Read more
NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD. The filing comes after Mesoblast was informed by FDA at the end of March that, following additional consideration, the available clinical data from the...Read more
WALTHAM, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has completed the resubmission of its Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, as a potential new treatment for patients with...Read more
The letter did not identify any issues with the efficacy or safety data submitted in the application BASKING RIDGE, N.J. & RAHWAY, N.J. / Jun 26, 2024 / Business Wire / The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (TSE: 4568) and Merck’s (known as MSD outside of the United States and Canada) (NYSE:...Read more
SAN DIEGO, June 25, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Pre-BLA (Biologics License Application) meeting with the Company in the third quarter of 2024 for deramiocel (CAP-1002), for the treatment of Duchenne...Read more
Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs TREMFYA® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn's disease GALAXI includes data demonstrating superior outcomes for...Read more
Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab Longer overall survival, progression-free survival and duration of response also observed with subcutaneous amivantamab RARATIN, N.J., June 17, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a Biologics License Application...Read more
FDA Grants Pre-BLA Meeting Request and Rolling BLA Submission after Review of HOPE-2 and HOPE-2 OLE 3-Year Results SAN DIEGO, June 11, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the successful completion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) on...Read more
TOKYO and CAMBRIDGE, Mass., June 9, 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 the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®)...Read more
TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive...Read more
Target Action (PDUFA) Date set for November 29, 2024 If approved, zanidatamab will be the first HER2-targeted treatment specifically indicated for patients with HER2+ locally advanced or metastatic biliary tract cancer DUBLIN, May 29, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License...Read more
Acceptance based on results from the pivotal Phase 3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients RAHWAY, N.J. / May 29, 2024 / 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...Read more
Updated Prescription Drug User Fee Act (PDUFA) goal date of December 29, 2024 PRINCETON, N.J. / May 21, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with...Read more
First Allogeneic T-Cell Therapy BLA Submission to U.S. Food and Drug Administration If Approved, Tab-cel Would be First Approved Therapy in U.S. for EBV+ PTLD Acceptance of BLA Will Trigger $20 Million Milestone Payment from Pierre Fabre Laboratories, with Potential for Additional $60 Million Milestone Upon FDA Approval THOUSAND OAKS, Calif. / May 20, 2024 / Business Wire / Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in...Read more
ALACHUA, Fla. and TAMPA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, is pleased to announce that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for licensure of Avance Nerve Graft® on May 15, 2024. “Today’s milestone...Read more
TOKYO and CAMBRIDGE, Mass., May 14, 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 has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand...Read more
EMERYVILLE, Calif., May 14, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) today provided a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response...Read more
PDUFA target action date of November 13, 2024 WARREN, N.J., May 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of AADC deficiency. The application has been granted Priority Review with a target regulatory action date of November 13, 2024. "We are...Read more
If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell Current treatment options for adolescents with CRSwNP leave many patients with uncontrolled disease and often result in the recurrence of nasal...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab...Read more
Application based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor The FDA assigned a target action date of February 28, 2025 PRINCETON, N.J. / May 06, 2024 /...Read more
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
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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