FDA has partnered with Flatiron Health to assess the use of real-real world data to demonstrate the safety and efficacy of cancer immunotherapies.

Gilead names a COO, Sanofi loses a top exec and the management churn continues at Valeant. Plus more hirings, firings and retirings throughout the industry.

The FDA handed down a major shock to AstraZeneca yesterday when it rejected its key hyperkalemia drug ZS-9, leaving potential rival Relypsa’s shares to jump in…

Clinicians looking for a reliable, controlled method to treat a host of recovering opioid addicts will now have a new resource in the armamentarium.

A few weeks after the FDA slapped a clinical hold on GlaxoSmithKline’s late-stage work on an experimental drug for a rare cardiac condition, the pharma giant…

A trio of Israeli biotechs have completed the initial filings for IPOs to raise up to $130 million each--but are holding off until demand picks up.

Bavarian Nordic has posted top-line data from a Phase I trial of its respiratory syncytial virus vaccine, setting it up to start larger study later this year.

A startup has picked up a Merck Serono castoff, signed up the R&D chief who axed the drug and set about turning it into a multiple myeloma combo treatment.