Researchers call for reevaluation of the iPLEDGE isotretinoin program and exploration of new approaches to lower fetal exposure to the drug.
Pear Therapeutics says it filed a request for marketing authorization with FDA for its Somryst prescription digital therapeutic to treat chronic insom...
Presenters at an FDA/Duke Margolis Center conference discuss FDA interest in risk-based quality management, including clinical trial monitoring.
FDA is expected to act by mid-2020 on an Allergan NDA for Bimatoprost SR indicated for reducing intraocular pressure in patients with open-angle glauc...
The Office of Generic Drugs science and research report for FY 2018 says 13 research contracts and 11 grants for innovative research were funded.
Federal Register notice: FDA submits to OMB an information collection extension for Center for Devices and Radiological Health Appeals Processes.
Novartis says it has reserved about $700 million to settle U.S. government allegations that it illegally enticed physicians to prescribe its drugs.
FDA accepts for review a Horizon Therapeutics NDA for a new dosage form for Procysbi (cysteamine bitartrate) delayed-release oral granules in packets...