On September 10, join this virtual event to hear industry-leading insights to improve operational efficiency and regulatory ...

A major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, the FDA found in a ...

This is the web edition of D.C. Diagnosis, STAT's twice-weekly newsletter about the politics and policy of health and ...

Ionis Pharmaceuticals won FDA approval for a drug that prevents painful swelling attacks triggered by a rare genetic ...

Neuroscientists have long held that the brain reorganizes itself when a body part is amputated. A new study says that’s not ...

The FDA's controversial rejection of a skin cancer therapy from Replimune Group has prompted Krystal Biotech to shut down of ...

Soleno Therapeutics CEO responds to a 415-page short-seller report alleging safety issues tied to the company's newly ...

This week on "The Readout LOUD," we discuss Viking Therapeutics' obesity flop and dish on the growing "pharm to table" movement.

Epic Systems announced a bevy of new AI products at the annual meeting for its EHR customers this week, including an AI scribe and AI assistants aimed at clinicians, patients, and admin staff. My ...

CVS Health will not add Gilead Sciences' new HIV prevention drug to its commercial plans for now, despite the medicine's proven effectiveness ...

The FDA has agreed to speed up a review of a rare disease drug developed by Stealth BioTherapeutics, a notable step after the company said it may have to close its doors otherwise.

Morning. Today, we see fallout from the FDA’s rejection of Replimune’s melanoma drug affecting another biotech, learn how Sarepta’s decision-making has affected a patient population that hasn’t always ...