Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...

Jacob Sands, MD, discusses the data that support the FDA accelerated approval of Dato-DXd in EGFR-positive non–small cell ...

Replimune (NASDAQ:REPL) climbed more than 100% on Wednesday as Cantor Fitzgerald upgraded the cancer drug developer, citing a potential reversal of an FDA decision that rejected its lead drug ...

FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...

As July concludes, the landscape of hematologic oncology continues to evolve, with notable progress in multiple myeloma, ...

The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as ...

Vinay Prasad, the top vaccine regulator and chief scientific officer at the Food and Drug Administration (FDA) and a critic ...

Early research hints that methylene blue may help with bipolar disorder, but safety and dosing questions remain.

As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more ...

After our editorial, the agency relents to allow a Duchenne treatment.

Apellis Pharma (APLS) stock in focus as the FDA expands the label for its injectable therapy Empaveli to treat rare kidney ...