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 ...
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 Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential ...
Precigen: UltraCAR-T Development Brings Another Side Of Pipeline Advancement
The last time I wrote about Precigen (NASDAQ:PGEN) it was with respect to a Seeking Alpha article entitled "Precigen: RRP ...
The Pharma Letter1d
Odronextamab BLA resubmission accepted for FDA review
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics ...
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) ...
Opthea announces anticipated milestones
Filter, analyze, and streamline your search for investment opportunities with TipRanks’ Stock Screener. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial ...
Managed Healthcare Executive1d
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 ...
manilastandard4h
IPOPHL seeks to resolve more IP violation cases
The Intellectual Property Office of the Philippines (IPOPHL) said it expects a continued reduction in the resolution time of ...
Organogenesis (ORGO) Q4 2024 Earnings Call Transcript
Organogenesis ( ORGO -5.54%) Q4 2024 Earnings Call Feb 27, 2025, 5:00 p.m. ET ...
Targeted Oncology1d
FDA Accepts Odronextamab BLA in Relapsed/Refractory Follicular Lymphoma
The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after ...
Scholar Rock Holding Corporation (NASDAQ:SRRK) Q4 2024 Earnings Call Transcript
Operator: Good morning and welcome to Scholar Rock’s Fourth Quarter Financial Results and Business Update Call. All participants will be in listen-only mode. After the company’s […] ...