FDA, Regeneron and BLA

Regeneron gets FDA Review acceptance for odronextamab's resubmitted BLA
Regeneron Pharmaceuticals (NASDAQ:REGN) said on Wednesday that the U.S. FDA has accepted its resubmitted Biologics License Application for odronextamab, a treatment for patients with relapsed or refractory follicular lymphoma who have undergone at least two prior therapies.
Regeneron announces FDA accepted for review BLA for odronextamab
Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for review the resubmission of the
FDA Accepts BLA Resubmission for Follicular Lymphoma Drug, Odronextamab
The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
Odronextamab BLA resubmission accepted for FDA review
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
FDA Accepts Odronextamab BLA in Relapsed/Refractory Follicular Lymphoma
The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after phase 3 trial enrollment milestone.
Linvoseltamab BLA Resubmission Accepted by FDA for Review
The FDA accepted Regeneron’s BLA resubmission for linvoseltamab in relapsed or refractory multiple myeloma, with a decision expected by July 10, 2025.
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FDA Accepts for Review Precigen RRP Gene Therapy Candidate
PRGN-2012—which Precigen has begun to call by its generic name of zopapogene imadenovec—is a gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus ...
Capricor Therapeutics: Heavily Derisked After BLA Submission And OLE Data
Capricor Therapeutics filed a BLA for deramiocel, showing promising results in slowing cardiac dysfunction in DMD ...
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Deadly BLA Attack in Balochistan Kills 18 Pakistani Security Personnel
Eighteen Pakistani security personnel were killed while attempting to stop an armed attack by the Baloch Liberation Army (BLA) in the Kalat district of Balochistan late Friday night, the Pakistan ...
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Outlook Therapeutics Advances ONS-5010 / LYTENAVA™ BLA Resubmission and Prepares for European Commercial Launch in 2025
Outlook Therapeutics, Inc. announced that it is on track for the resubmission of its Biologics License Application (BLA) for ONS-5010 (LYTENAVA™) in the first quarter of 2025, aiming for initial ...
Telix kidney cancer imaging agent granted FDA priority review
Australian biotech Telix Pharmaceuticals (NASDAQ:TLX) announced late Tuesday that the U.S. Food and Drug Administration (FDA) has accepted its marketing application for TLX250-CDx and granted it ...
FDA accepts lerodalcibep application to lower LDL cholesterol
LIB Therapeutics announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA ...
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BLA Reports Strong 42% Profit Growth in 2024
Bangkok Life Assurance Public Company Limited (BLA) has announced its financial performance for the fourth quarter of 2024, reporting a net profit of THB 954 million, representing a remarkable 166% ...
Branding Latin America Expresses Concerns on Foreign Arbitration Tactics Threatening Latin American Sovereignty
LONDON, GB / ACCESS Newswire / February 20, 2025 / Branding Latin America (BLA), a leading consultancy specializing in Latin American affairs, is ...