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Amgen is suing the FDA, requesting that its Sensipar medication be granted six additional months of pediatric market exclusivity after it completed three of four pediatric clinical trials requested by the agency. Read More
Less than two weeks on the job and FDA Commissioner Scott Gottlieb is getting pressure from Capitol Hill to change official FDA guidance for compounders. Read More
More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read More
FDA Commissioner Scott Gottlieb laid out his early priorities before members of Congress Thursday, and announced that the hiring freeze on the agency had officially been lifted. Read More
Sen. Claire McCaskill (D-Mo.) asked Mallinckrodt for more details on price increases for Ofirmev, the company’s injectable version of acetaminophen. Read More
A television advertisement for the Orexigen Therapeutics weight loss drug Contrave (naltrexone HCl and bupropion HCl) drew a warning from the FDA’s Office of Prescription Drug Promotion (OPDP), the office’s first of 2017. Read More