FDA Commissioner Dr. Marty Makary joins 'Squawk Box' to discuss his meeting with CEOs of major pharmaceutical and biotech ...

Vinay Prasad, a top FDA official, suddenly departed after a series of controversial decisions about a Duchenne gene therapy ...

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion ...

Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and ...

The founder and former CEO of several pharmaceutical companies, Tidmarsh was tapped by FDA Commissioner Marty Makary, MD, MPH ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Speakers at a congressional briefing on July 22 called on the FDA to take action against the marketing and distribution of ...

AbbVie, Bristol Myers Squibb and Eli Lilly appear “relatively well-positioned,” while Novartis and Roche look more at risk, ...

The U.S. Food and Drug Administration has approved PTC Therapeutics' oral drug to treat a rare inherited metabolic disorder ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...