FDA bans Red 3 dye from food and drugs. A scientist explains the artificial color's health risks and long history
Red 3—also called FD&C Red No. 3, erythrosine or E127—has been widely used in food, cosmetics and pharmaceuticals since its ...
gastroenterologyadvisor1d
FDA Proposes Simple Front-of-Package Nutrition Labeling
The U.S. Food and Drug Administration is proposing that simplified food nutrition labels be placed on the front of food packages.
FiercePharma1d
Teva's multiple sclerosis stalwart Copaxone gets FDA boxed warning for anaphylaxis risk
After years of legal wrangling surrounding Teva’s Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in ...
The FDA is about to make weight-loss drugs a lot harder to get
Lots of people are on cheaper compounded weight-loss drugs that mimic brands like Ozempic, Wegovy, and Zepbound. They're ...
Medexus Announces FDA Approval of GRAFAPEX (treosulfan) for Injection and Provides Business Update
GRAFAPEX™ (treosulfan) for injection is approved by the FDA for sale and use in the United States only and is not intended for export outside the United States. Medexus makes no representation that ...
Laurus Labs arm gets one U.S. FDA observation after post-marketing adverse drug experience inspection
Laurus Labs' U.S. subsidiary receives Form 483 from FDA after PADE inspection, to address observation promptly.
JD Supra3d
Patent Poetry: Federal Circuit Reverses Novartis Patent Decision
The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s ...
FiercePharma3d
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...
STAT3d
A next-generation form of chemotherapy wins FDA approval
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
WCJB3d
Family seeks answers from FDA after 9-year-old son nearly dies from E. coli
The boy's family believes his sickness was caused by an E. coli outbreak linked to romaine lettuce that affected 88 people ...