Fda
FDA issues warning against using epinephrine nasal solutions from BPI Labs, Endo USA
The FDA has advised health care professionals that they should not use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC and Endo USA.
FDA approves sale of Zyn nicotine pouches following extensive review
The FDA announced it has authorized the marketing of 20 Zyn nicotine pouch products, citing their greater health benefits vs. cigarettes and other tobacco products.
FDA approves therapies for colorectal cancer, mantle cell lymphoma
The FDA approved two oncology regimens on Jan. 16.
IBD drug market rattles as Lilly’s Omvoh nabs FDA approval for second IL-23p19 in Crohn’s
The FDA has approved Omvoh for the treatment of moderately to severely active Crohn’s disease, making it the second interleukin-23p19 specific inhibitor approved for both major types of inflammatory bowel disease, Lilly reported.
FDA bans red dye popular in candy, other ultraprocessed foods
The FDA announced a ban on the controversial red dye no. 3, which gives food and drinks a bright, cherry red color and has also been associated with cancer in laboratory rats.
FDA proposes cap on nicotine levels in cigarettes
The FDA has proposed limiting the level of nicotine in cigarettes and other combusted tobacco products like cigars and pipe tobacco to make them “minimally or nonaddictive,” according to a press release from the agency.
FDA grants biologics license application for monthly IV Leqembi
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat individuals with mild cognitive impairment or mild dementia consistent with early stage Alzheimer’s disease.
FDA clears investigational new drug application for lorundrostat in OSA, hypertension
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, lorundrostat, in adults with obstructive sleep apnea and hypertension, according to a press release.
FDA proposes rule requiring simplified nutrition label on the front of most packaged foods
The FDA has proposed a rule requiring a new nutrition label on the front of most packaged foods, offering consumers easily visible information about the presence of key nutrients, according to a press release.
FDA grants fast-track designation to small molecule for Fragile X
The FDA has granted fast-track designation to an investigational small molecule to treat individuals with Fragile X syndrome, according to the manufacturer.