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 ...
ophthalmologytimes2h
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) ...
Targeted Oncology32m
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, ...
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 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 ...
Targeted Oncology1h
FDA Grants RMAT Designation to Nogapendekin Alfa in Pancreatic Cancer
The FDA granted RMAT designation to nogapendekin alfa and CAR-NK for reversing lymphopenia in patients with cancer, with ...
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 ...
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 ...
pulmonologyadvisor3h
FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...
Novavax Q4 Earnings Review: Long-Term Downsizing Plan Suggests Sell Rating
Novavax, Inc. faces declining revenues and high risks despite the Sanofi deal and cost-cutting measures. Click here for my ...