FDA officially authorizes Zyn nicotine pouches for sale following health review
The U.S. Food and Drug Administration formally authorized Zyn nicotine pouches for sale after conducting an "extensive ...
Outgoing FDA chief flags online weight loss drug dangers
Current laws and regulations are not enough to protect Americans from the risks of compounded versions of popular weight loss ...
Smithsonian Magazine on MSN3d
FDA Bans Red Dye No. 3 From Food, Beverages and Ingested Drugs, Citing Link to Cancer in Lab Rats
The synthetic additive found in thousands of food products will now be phased out by 2027, but advocates say the agency's ...
Hosted on MSN4h
Arrowhead’s plozasiran set for FDA review as Tryngolza challenge looms
An FDA approval later this year for Arrowhead’s plozasiran in FCS would put it in direct competition with Ionis’ Tryngolza.
JD Supra5h
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
Cure Today6d
FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC
The Food and Drug Administration has accepted and granted priority review to a new drug application for sunvozertinib.
The American Journal of Managed Care7h
In a First-of-Its-Kind Decision, FDA Will Allow Marketing of Nicotine Pouches
This marketing decision from the FDA covers 2 nicotine strengths, 3 mg and 6 mg, and 10 flavors of the small tobacco-free ...
Hosted on MSN1h
CergenX wins FDA breakthrough designation for neonatal EEG assessment tool
Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...
Benzinga.com6d
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
FDA sets August 31, 2025, as the action date for Eisai and ... patients with Mild Cognitive Impairment or mild dementia stage ...
Drug to treat rare pediatric disease accepted for FDA review
A subsidiary of a Miami-based company is inching closer to FDA approval for a drug that treats a rare pediatric disease.
JD Supra7h
FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations
The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization ...
The National Law Review3d
FDA Revokes Authorization for the Use of Red Dye No. 3 in Food and Ingestible Drugs
On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization ...