MedPage Today1h
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
US FDA approves expanded use of Lilly's bowel disease drug
Eli Lilly said on Wednesday the U.S. health regulator has approved its drug to treat adults with moderate-to-severe Crohn's ...
Eli Lilly Receives FDA Approval for Crohn’s Disease Treatment
Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely-active Crohn’s ...
Billed as nonaddictive, new pain pill could soon win FDA approval
A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...
FDA Approves Zyn Pouches For Sale As Less Harmful Alternative To Cigarettes
The increasingly popular nicotine pouches pose a lower risk of cancer than cigarettes, U.S. health officials said.
FDA approves Zyn nicotine pouches, citing health benefits for adult smokers
Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris ...
Targeted Oncology3h
FDA Approves Axatilimab for Chronic GVHD in New Vial Sizes
Axatilimab has gained FDA approval in 9 mg and 22 mg vials, expanding treatment options for patients with chronic GVHD after ...
Philip Morris stock rises on FDA's first nicotine pouch approval
Shares of Philip Morris International Inc. (NYSE:PM) rose 1% following the U.S. Food and Drug Administration's (FDA) ...
FDA Finally Revokes FD&C Red No. 3 For Food And Drugs
The FDA revokes FD&C Red No. 3 authorization due to cancer concerns under the Delaney Clause, impacting food and drug ...
BioPharma Dive2h
Lilly’s Omvoh approved by FDA for Crohn’s
The clearance broadens use of Omvoh, which is part of a slate of new medicines Lilly is counting on to build on its success ...
BioSpace3d
5 Novel FDA Approvals Notched in 2024
Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming ...
BioPharma Dive1d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...