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 ...

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 ...

Eight years after it was established partly by AstraZeneca, Dizal Pharmaceuticals has gained its first FDA approval, winning an accelerated nod for Zegfrovy (sunvozertinib) to become the only ...

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

KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral treatment for a type of hereditary swelling disorder, sending its shares ...

An AI healthcare platform analyzed 13 years of FDA data to identify companies with highest recall rates and most dangerous ...

Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.

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