Vinay Prasad, director of the Center for Biologics Evaluation and Research, will leave the FDA at the end of April, an agency spokesperson confirmed on Friday. It is his second departure from the position: He briefly left the post in July following backlash over his regulatory decisions, and returned only two weeks later in August.

Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically into the brain, that the FDA was “pressured” to approve even after finding no clinical benefit to patients.

FDA Commissioner Marty Makary highlighted rapid approvals of the lung cancer drug Zongertinib and the multiple myeloma therapy Tec-Dara. ・Retail traders accused regulators of favoring big pharma, calling the approvals a “rubber stamp” and arguing the FDA moves faster for large drugmakers.

Scientific, political pressures colliding at FDA, delaying rare disease treatment for patients who have few or no options, experts said at CNBC Cures Summit.

Johnson & Johnson’s standout trial results for its Tecvayli and Darzalex Faspro pairing in previously treated relapsed or refractory multiple myeloma have earned the company the third ultra-spe | FDA Commissioner Marty Makary,

Recent decisions at the FDA threaten to turn its disagreements with the drugmaker UniQure into another political headache for the Trump administration.

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administration.

The reward for fast regulatory work will come in the form of a quarterly bonus, to be paid out to FDA staffers starting in August. Per the AP, payment amounts will be based on vague “weighted time savings,” as well as “work quality and work complexity.”