FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food ...
ophthalmologytimes7h
Outlook Therapeutics resubmits BLA for ONS-5010 for treatment of wet AMD
Outlook Therapeutics has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...
Outlook Therapeutics re-submits BLA to U.S. FDA for ONS-5010
Outlook Therapeutics (OTLK) announced it has re-submitted its Biologics License Application, BLA, to the U.S. Food and Drug Administration, ...
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 ...
Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
FDA decision expected by July 30, 2025TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) ...
The Pharma Letter2d
Odronextamab BLA resubmission accepted for FDA review
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics ...
Managed Healthcare Executive2d
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 ...
4DMT Reports Full Year 2024 Financial Results, Operational Highlights and Expected Upcoming Milestones
Presented positive interim data through 52 weeks and beyond for 4D-150 in wet AMD from PRISM Phase 1/2 clinical trial highlighting robust and ...
Targeted Oncology2d
FDA Accepts Odronextamab BLA in Relapsed/Refractory Follicular Lymphoma
The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after ...
The Bangkok Post on MSN7d
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, ...
ThePrint7d
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 ...
Regeneron Pharmaceuticals, Inc.: Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission ...