FDA sends Evoke Pharma a multi-disciplinary review letter on its 505(b)(2) NDA for Gimoti (metoclopramide), a nasal spray indicated for treating gastr...
Intellipharmaceutics International resubmits an NDA for its oxycodone ER product candidate, indicated for treating pain.
Novartis files a Lanham Act suit against Janssen seeking to stop it from making false and misleading claims associated with Janssens Tremfya, indicate...
Former Insys Therapeutics sales vice president Alec Burlakoff testifies in Boston federal court on how he followed orders to recruit physicians and pa...
CDER Office of Prescription Drug Promotion cites Phoenix Molecular Imaging Center for promoting an investigational drug, 11C-acetate, as safe and effe...
FDA clears an eNeura 510(k) clearance for its single-pulse Transcranial Magnetic Stimulation device and expanded use in acute and preventive treatment...
FDA agrees to accept a CytoDyn rolling BLA submission for PRO 140 (leronlimab), a CCR5 antagonist, indicated for blocking HIV-1 from entering and infe...
Federal Register notice: FDA submits to OMB an information collection extension for Financial Disclosure by Clinical Investigators.