STAT6h
Former FDA lawyers join tobacco industry in ‘epic’ fight against the agency
Gorji joined DLA Piper, one of the biggest law firms in the world, as a litigation partner, adding to its FDA team, which ...
FierceBiotech2h
Lykos accepts FDA’s view that reviving rejected MDMA therapy’s fortunes requires fresh phase 3 trial
Lykos Therapeutics may have shed three-quarters of its staff in the wake of the FDA's rejection of its MDMA candidate for ...
FierceBiotech5h
Vertex posts full pain data ahead of FDA ruling, unpacking combo results, Vicodin miss and stellar safety
The FDA is set to rule on whether to approve suzetrigine by Jan. 30. Leerink analysts said they think the FDA could reach a ...
Amid backlash, FDA changes course over shortage of weight-loss drugs
The FDA said Eli Lilly’s weight-loss drugs were no longer in shortage on Oct. 2, preventing pharmacies from making cheaper ...
LENZ Therapeutics Shares Rise After FDA Accepts Application for Potential Eye Condition Treatment
LENZ Therapeutics said the submission for the treatment of presbyopia is supported by the positive data results from a Phase 3 study. Aceclidine is a new chemical entity in the U.S. and isn't approved ...
Kellogg's Froot Loops cereals are in danger of being recalled by the FDA for this reason
Kellogg’s Froot Loops cereals are some of the most popular in the United States, but food safety protesters are demanding the ...
FDA asks Texas court to shut down COVID-19 vaccine records lawsuit
The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to ...
Nationwide Antidepressant Recall Update As FDA Sets Risk Class
The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 ...
FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...
Food Safety News11h
FDA warns foreign seafood importers about serious HACCP violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The FDA on Thursday approved an injectable drug that eased Parkinson's disease symptoms and improved motor fluctuations in ...
STAT4d
The biggest challenge facing the FDA’s new Rare Disease Innovation Hub
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting ...