FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.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 warns CSL Behring that a direct-to-consumer TV spot for its Hizentra overstates the drugs effectiveness and minimizes its risks.
FDA warns Bellevue, WA-based SeniorLife.AI about multiple violations in its illegal marketing of an artificial intelligence-based device intended to s...
FDA issues an early alert about a Medline recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Catheters based on an earl...
FDA warns Indias Somerset Therapeutics about CGMP and Field Alert Reporting violations in its production of finished drugs.