Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, ...
Biohaven's NDA for Troriluzole was accepted by the FDA, potentially leading to approval in Q3 2025. Click here to find out ...
A large number of Australian biotechs are waiting for US FDA product approval – or are on the cusp of ... Read More The post ...
Hims & Hers is under scrutiny for promoting compounded weight-loss drugs in a Super Bowl ad without clear FDA approval or ...
U.S. Food and Drug Administration (FDA) recently accepted the Biologics License Application (BLA) for RP1 plus nivolumab in advanced melanoma for priority review with a PDUFA date of July 22, 2025 ...
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
Travere’s stock price climbed by 14% following the announcement it will seek an FDA label expansion for Filspari.
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
Twenty years ago, in 2004, Congress passed the Project BioShield Act, which established the Biomedical Advanced Research and ...