Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

The US Food and Drug Administration (FDA) has accepted MSD’s doravirine/islatravir (DOR/ISL) new drug application (NDA) for ...

As one FDA initiative works to sustain the momentum of rare disease research, other events threaten to slow progress.

MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet ...

FDA staff cuts have claimed negotiators integral to upcoming reauthorization talks on the FDA's funding-dependent user fee program, Reuters reports.

As FDA kicked off the drug user fee reauthorization process, Commissioner Marty Makary said he’d like to see lower fees paid ...

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up.

The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.

The FDA’s Oncologic Drugs Advisory Committee has voted against the benefit/risk profile of GSK’s Blenrep just days before the drug’s PDUFA date.

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool ...