Pennsylvania attorney general Dave Sunday says 49 states are sharing a $202 million settlement with Gilead Sciences to resolve charges that the compan...
Two stakeholders urge FDA to use the PDUFA 8 reauthorization to emphasize the need for congressional funding and take steps to improve transparency an...
Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm, whi...
FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexual desire in post-menopausal women.
FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the companys Duchenne muscu...
Apnimed announces positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-daily oral pill for t...
Gizmodo reports that FDA employees who have used Elsa told CNN the AI tool makes up reports and hallucinates confidently.
Baxter Healthcare recalls (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attachment.
