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 ...
BridgeBio Pharma Is A Buy On Dips After Attruby's FDA Approval
Attruby's approval makes BridgeBio Pharma a competitor to Vyndaqel, with significant potential for growth and milestone ...
BioPharma Dive16h
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 ...
FDA bans Red No. 3 food dye in food, drinks: Here's what to know
The FDA announced on Wednesday that it has banned the use of Red No. 3, an additive used to give food and drinks a cherry-red ...
BioSpace20h
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
FDA Approves Weight-loss Drug Zepbound For Sleep Apnea – Will Insurance Cover This $1000-Per-Month Medication?
Zepbound is a dual-activating medication that combines glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like ...
FDA bans red dye No. 3 from foods
The ban removes it from the list of approved color additives in foods, dietary supplements and oral medicines, such as cough ...
FDA bans Red No. 3. What has Robert F. Kennedy Jr. said about food dyes?
Manufacturers who use Red No. 3 in food will have until Jan. 15, 2027 to reformulate their products, while those who use the ...
Eli Lilly’s Omvoh for Crohn’s disease approved by FDA
Eli Lilly (LLY) announced that the FDA has approved Omvoh for the treatment of moderately to severely active Crohn’s disease in adults. Omvoh ...
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 ...