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.
While acknowledging the many complexities of product development, sponsor teams should factor in these six guiding principles when planning programs for regulatory submission.
