FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes available after a dru...
The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Review Voucher program.
FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.
Eli Lilly reports that it oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisks oral semaglutide in...
Former CDC director Susan Monarez says FDA and other health agencies are facing similar political pressure that she experienced to fire senior career ...
The Department of Justice charges David Ralph Webber with smuggling and selling misbranded prescription drugs marketed as sexual enhancement supplemen...
FDA publishes a guidance to help sponsors with clinical trials for drugs to treat symptomatic nonerosive gastroesophageal reflux disease in adults.
Johnson & Johnson reports favorable data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies that showed its experimental psoriasis drug icotrokinra outpe...
