MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II ...
Kexing Biopharm announced that its investigational Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes has successfully completed a Type II Drug Master File (DMF) registration with the U.S.
A family in Bellevue is seeing life-changing results for their son, thanks to a clinical trial drug. However, getting the drug approved by the FDA has been faced with "technicalities." ...
United Therapeutics Corporation ( NASDAQ: UTHR) Bernstein 2nd Annual Global Healthcare Conference September 23, 2025 1:10 PM EDT ...
AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first European participants have been randomized in ...
The agency held a meeting to gather drugmakers' perspectives as it considers a draft guidance on how previously generated ...
The U.S. Food and Drug Administration issued warning letters to Eli Lilly , Novo Nordisk and telehealth firm Hims & Hers ...
By publishing complete response letters as soon as they are issued to drug sponsors, the FDA is expanding transparency in a ...
The U.S. Food and Drug Administration has declined to approve Scholar Rock's drug for a rare neuromuscular disease, citing ...
FDA assigns a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback