U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly ...

Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, ...
STAT

FDA taps AI executive to lead digital health center

Rick Abramson, formerly a chief medical officer at a subsidiary of Harrison.ai, which develops AI products to interpret ...

FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...

Shrimp Recall Update as FDA Sets Risk Level

Thousands of units have were potentially contaminated with a radioactive substance, which can increase the risk of cancer.
STAT

In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy

The top drug regulator at the FDA told staff she plans to question the safety of taking SSRIs in pregnancy and of RSV shots ...
Opinion

Editorial: FDA’s see-sawing on Moderna’s new mRNA flu vaccine is dangerous

The anti-science, anti-medicine mindset of Health and Human Services Secretary Robert F. Kennedy Jr. is killing people by quashing life-saving vaccines.

FDA reverses course on Moderna flu shot

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

FDA reverses course and will review Moderna’s mRNA flu shot, company says

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday, ...

FDA reverses course, will review Moderna’s mRNA flu vaccine candidate

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...

Moderna says the FDA will consider its new flu shot after resolving a public dispute

Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the ...
NOLA.com

Sen. Bill Cassidy calls for FDA overhaul: ‘Discoveries that never leave the lab help no one’

Cassidy is reacting to criticism from drug manufacturers of the review process, which he argues makes medicine more expensive.