News

The U.S. Food and Drug Administration has denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...
But an FDA panel recently attacked SSRI’s – a class of antidepressant drugs – and their use during pregnancy. Some doctors ...
The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid ...
A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules ...
PTC Therapeutics has long been trying to workshop its vatiquinone into a marketable treatment for Friedreich's ataxia (FA) after a phase 3 fail in 2023. | Despite missing its primary endpoint in a ...
The U.S. Food and Drug Administration placed a clinical hold on a study of BiomX's cystic fibrosis treatment in order to review data on the third-party nebulizer used to deliver the drug. Patient ...
The FDA granted breakthrough therapy designation to Ifinatamab deruxtecan for some with extensive-stage small cell lung ...
The FDA and Fromi USA recalled Brie cheese wheels sold in New York because they could be contaminated with Listeria, an ...
The FDA’s recent issue of five warning letters to brands illegally marketing whipped, mousse and foam sunscreen products ...
The FDA said in letters to five sunscreen makers that they are not authorized to market sunscreen sold in mousse or whipped form.
The FDA has issued a recall of over 4,500 lb. of White Cheddar Cheese, 640 lb. of Monterey Jack Cheese, 240 lb. of 100% Grass ...
The U.S. Food and Drug Administration has declined to approve PTC Therapeutics' drug to treat a rare genetic disorder with ...