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

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 ...

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

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

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

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

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

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

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 ...