FDA approves an expanded use for Axsome Therapeuticss Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation associat...
An FDA advisory committee votes 6 to 3 against supporting AstraZenecas investigational breast cancer therapy camizestrant.
Following a reported patient death, FDA places a hold on new patient enrollment at U.S. sites participating in ENIGMA-TRS 2 study, a late-stage trial ...
A Clinical Trial Vanguard online post makes the case for further FDA guidance so drug trial sponsors can successfully incorporate artificial intellige...
A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic.
FDA medical reviewers ask the Oncologic Drugs Advisory Committee to consider their concerns about the benefit-risk assessment of AstraZenecas breast c...
FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile p...
FDA accepts for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen.
