Zachary Brennan

Cat­a­lyst Phar­ma­ceu­ti­cals’ con­tro­ver­sial $375,000 rare au­toim­mune dis­ease drug now won’t face gener­ic com­pe­ti­tion from Te­va un­til Feb. 25, 2035, thanks to a patent set­tle­ment an­nounced

Japan-based Seik­a­gaku will face an FDA ad­vi­so­ry com­mit­tee on Fri­day, with the agency rais­ing con­cerns ahead of the meet­ing re­gard­ing the ef­fi­ca­cy of its con­do­liase

New an­ti-obe­si­ty drugs should meet a min­i­mum lev­el of weight loss to be con­sid­ered for ap­proval, the FDA said Tues­day, tak­ing the rare step of

With two weeks un­til Pres­i­dent-elect Don­ald Trump’s ad­min­is­tra­tion takes over, the FDA on Mon­day re­leased dozens of new draft and fi­nal guid­ance doc­u­ments cov­er­ing every­thing

No­vo Nordisk is con­tin­u­ing its cit­i­zen pe­ti­tion cru­sade at the FDA, this time aim­ing to stop the com­pound­ing of Vic­toza, its block­buster GLP-1. The push