The U.S. Food and Drug Administration called for Eisai to pull the company’s Belviq and Belviq XR for weight loss from the market after clinical trials demonstrated an increased incidence of cancer in users.
The U.S. FDA denied Lexicon Pharmaceuticals Inc.’s appeal against the rejection of the add-on treatment Zynquista for type 1 diabetes, marking the company’s third major setback during 2019.
The U.S. Food and Drug Administration division that handles new and existing oncology drugs was renamed and restructured.
The U.S. Food and Drug Administration gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease.
The U.S. Food and Drug Administration will create a new office to improve the process of reviewing new drugs for approval.
The President-Elect Donald Trump Administration has a new website and has updated – sort of – Trump’s intended policies for healthcare and biopharma.
The ninth batch of presidential candidate Hillary Clinton’s emails released by WikiLeaks has some biopharma gossip that includes Clinton’s team discussing the FDA’s commissioner and it’s so-called “war on pharma.”
While acknowledging the many complexities of product development, sponsor teams should factor in these six guiding principles when planning programs for regulatory submission.
The FDA and international authorities have formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers.