CDER updates its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated products.
FDA posts a final guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steato...
FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.
McKinsey & Co. agrees to pay $650 million to settle both criminal and civil investigations into its advisory work with Purdue Pharma and the marketing...
FDA says it has identified serious liver injuries in patients without cirrhosis of the liver being treated for primary biliary cholangitis with Interc...
Keros Therapeutics stops some dosing in a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulm...
A detailed ProPublica investigative report says FDA failed to inspect a Glenmark Pharmaceuticals facility in India that had multiple drug recalls in a...
In a Time interview, president-elect Donald Trump said it has always been his commitment to preserve access to abortion pills, but also said the issue...
