FDA, BLA and Regeneron

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.
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 ...
GEN5h
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 ...
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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, ...
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 ...
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BLA claims responsibility for attack on Pakistani Forces in Balochistan
The Baloch Liberation Army has stated that it carried out coordinated attacks on multiple military checkpoints and personnel stationed in the Shaban region of Pakistan's biggest province - Balochistan ...
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 ...
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 ...
Olly Murs shares health update after cancelling live show just hours before going on stage
Olly Murs has issued a health update after he was once again forced to cancel a performance hours before going on stage. The ...