MedPage Today9hOpinion
REMS for Clozapine Must Go
FDA convened a joint meeting of its Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs ...
STAT2d
As officials prepare for WHO-led flu vaccine meeting, many wonder: Will the U.S. show?
Each year, flu experts from around the world gather to map out recommendations for next winter's flu vaccine. This year, it's ...
Small-Cap OS Therapies Inks Commercial Manufacture Agreements For Lead Cancer Drug For Rare Type Of Bone Cancer
HER2, a HER2-targeted immunotherapy, with plans for FDA submission following promising Phase 2b data in osteosarcoma.
manilatimes2d
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today ...
The American Journal of Managed Care12d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Travere Therapeutics stock soars on FDA meeting outcome
Shares of Travere Therapeutics (NASDAQ:TVTX) surged 14% Tuesday following the company's announcement of a successful Type C ...
Spur Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for FLT201, Its Gene Therapy Candidate for Gaucher Disease
FDA aligned on single-arm Phase 3 study to support potential accelerated and full approval On track to dose first patient in Phase 3 trial in second half of 2025 LONDON, Feb. 03, 2025 (GLOBE NEWSWIRE) ...
Pharmabiz3d
INmune Bio to submit BLA with US FDA seeking approval of CORDStrom to treat recessive dystrophic epidermolysis bullosa in paediatric patients
Boca Raton, Florida Wednesday, February 12, 2025, 16:00 Hrs [IST] ...
Business Insider12d
Spur Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for FLT201, Its Gene Therapy Candidate for Gaucher Disease
meeting with the U.S. Food and Drug Administration (FDA), supporting its planned Phase 3 trial for FLT201, an adeno-associated virus (AAV) gene therapy candidate for Gaucher disease type 1.
OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...