A BMJ investigation questions how FDA approved Mercks antibiotic Recarbrio in 2019 since it did not appear to meet agency requirements for substantial...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Cipla USAs Zemdri (plazomicin).
Viking Therapeutics provides encouraging top-line data from its Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic stea...
A Minnesota federal judge enters a $487 million judgment against Cameron-Ehlen Group, which does business as Precision Lens, for violations of the Fal...
FDA approves an expanded indication for Abbott spinal cord stimulation (SCS) devices treating chronic back pain in those who have not had or are not ...
Five stakeholders comment on an FDA question-and-answer draft guidance on using electronic systems, records, and signatures in clinical investigations...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals Onpattro (patisiran).
FDA issues Byondis a complete response letter on its BLA for SYD985 ([Vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresecta...
