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 ...
ophthalmologytimes2d
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) ...
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 ...
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, ...
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) ...
Precigen’s BLA for PRGN-2012 in papillomatosis granted priority review by FDA
Precigen (PGEN) announced the FDA has accepted the company’s biologics license application, or BLA, for PRGN-2012, an investigational ...
The Pharma Letter4d
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 Executive3d
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 ...
Precigen: UltraCAR-T Development Brings Another Side Of Pipeline Advancement
Precigen's PRGN-2012 and UltraCAR-Ts offer groundbreaking therapies. Read why PGEN stock is a strong pick, with major ...
Targeted Oncology4d
FDA Accepts Odronextamab BLA in Relapsed/Refractory Follicular Lymphoma
The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after ...
Targeted Oncology2d
FDA Grants Priority Review to TLX250-CDx in Kidney Cancer
The FDA granted priority review to TLX250-CDx for clear cell renal cell carcinoma imaging, with a PDUFA date of August 27, ...
Why INmune Bio, Inc. (INMB) is Skyrocketing So Far in 2025
We recently published an article titled Why These 15 Biotech Stocks Are Skyrocketing So Far In 2025. In this article, we are ...