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 ...
Zyn’s Flavored Nicotine Pouches Win Marketing Approval From FDA
The US Food and Drug Administration approved the marketing of 20 Zyn products to adults, the first time it has authorized ...
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 ...
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 ...
FDA grants IDE approval for NextBioMedical’s Nexsphere-F trial
The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's ...
STAT1d
Federal watchdog raises some concerns about the FDA’s accelerated approval program
The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with ...
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 ...
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 ...
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 ...
Monthly Prescribing Reference2h
Omvoh Approved for Moderately to Severely Active Crohn Disease
Mirikizumab is a humanized immunoglobulin G4 monoclonal antibody that selectively binds to the p19 subunit of human interleukin (IL)-23.