The FDA rejected Applied Therapeutics’ experimental treatment, govorestat, for a rare disease called classic galactosemia, ...

Bristol Myers Squibb is the latest pharma company to sue the federal government over its rejection of a proposed new model ...

FDA accepts Satsuma Pharmaceuticals' NDA resubmission for STS101 migraine drug. Hovione expands facilities in Ireland and New ...

Advanz Pharma's liver treatment Ocaliva lost EU marketing authorization following a court decision. The drug, used for ...

Kronos Bio announces 83% workforce reduction and CEO Norbert Bischofberger's departure, with CFO Deborah Knobelman taking ...

Outlook Therapeutics' ONS-5010 (bevacizumab) failed to meet its primary endpoint in a Phase 3 trial against Roche's Lucentis ...

Idorsia announces 270 potential layoffs, primarily affecting R&D and headquarters support functions. The company is ...

The transition team for President-elect Donald Trump was still searching for its next National Institutes of Health director ...

The Biden administration proposed a new rule Tuesday that would expand Medicare and Medicaid coverage of popular obesity ...

President-elect Trump selected Jay Bhattacharya, Stanford professor and Covid-19 lockdown critic, to lead NIH, and Jim ...

Axsome Therapeutics’ narcolepsy drug AXS-12 hit the primary endpoint in its Phase 3 ENCORE trial, showing a statistically ...

FDA extends review of Soleno Therapeutics' diazoxide choline extended-release tablets for Prader-Willi syndrome by three ...