The U.S. House Appropriations Committee votes to approve a spending bill to fund FDA for fiscal year 2027.
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...
