Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA ...

Face Rock Creamery issued a recall for its Vampire Slayer Garlic Cheddar Curds over possible Listeria monocytogenes contamination.

Some two dozen biotech developers of PROTACs, molecular glues and other types of protein-degrading drugs have sprung up over ...

The FDA has granted accelerated approval to Datroway for adults with previously-treated, locally advanced or metastatic EGFR-mutated NSCLC.

Clinical-stage biotech firm Mustang Bio (NASDAQ:MBIO) stock rallied 180% on Monday to £2.46 ($3.34) per share after the US Food and Drug Administration granted Orphan Drug Designation to its MB-101 ...

U.S. District Judge John Bates vacated directives from the Department of Health and Human Services and the Office of Personnel and Management. However, he denied a broader request to prevent HHS from ...

A new report from congressional researchers examines the state of law around a federal statute that prohibits gun possession ...

The firm’s rapid rise represents a burgeoning American health trend. Between 2019 and 2024 prescriptions for testosterone ...

Shares of Eton Pharmaceuticals rose sharply in premarket trading Tuesday after the pharmaceutical company said the Food and Drug Administration has accepted its application seeking approval of its ...

Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...

A young Pittsburgh-area police officer died by suicide and pointed to Lasik eye surgery complications as the reason.

Here are the key takeaways from the full Times Magazine story about the F.D.A.: The F.D.A.’s regulators have an enormous ...