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 ...

There’s a “reasonable probability” the recalled fruit will cause serious illness or death, the U.S. Food and Drug ...

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 ...

Rare genetic diseases are challenging for patients and their families—made all the more overwhelming because symptoms tend to ...

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 ...

As if to address the concerns of both groups, Kennedy's FDA announced in May that it approves covid boosters only for those over 65 or in other high-risk groups. The vaccine remains available to ...

Johnson & Johnson’s Abiomed has recalled automated controllers for its Impella heart pumps over a fault linked to three ...

Mesoblast shows promise with FDA progress and a strong pipeline, but limited data and execution risks persist. Learn why MESO ...

Earlier diagnoses and advancements in treatment options are providing hope for patients with endometrial cancer like Yaca.

The new system replaces pass/fail grades with a more practical approach that categorizes violations based on actual health ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...