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 ...
FDA’s START and CoGenT pilot programmes: Streamlining rare disease drug approvals
These initiatives represent a way to accelerate access to treatments that have historically faced longer regulatory pathways.
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 ...
Smithsonian Magazine on MSN3d
FDA Bans Red Dye No. 3 From Food, Beverages and Ingested Drugs, Citing Link to Cancer in Lab Rats
After decades of debate, the Food and Drug Administration (FDA) has announced a ban on Red Dye No. 3, a synthetic food ...
Cure Today5d
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.
RFK Jr. wants to improve Americans’ health. Here’s some advice from the outgoing FDA chief
Robert F. Kennedy Jr. has big plans for the FDA if he's confirmed as Secretary of Health and Human Services. FDA Commissioner ...
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 ...
The American Journal of Managed Care59m
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 ...
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 ...
JD Supra1h
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 ...