FDA publishes two guidances relating to the CDRH/CBER Q-submission process.
GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...
CDERs Accelerating Rare Disease Cures online newsletter says there were 26 orphan drug approvals in 2024 and lists four approvals already in 2025.
In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault against the pharmaceutical industry and direct-to-consum...
Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDERs Office of Prescription Drug Promotion can adequately regulate prescription dru...
Veru announces positive topline results from its Phase 2b QUALITY clinical trial that is evaluating enobosarm when added to semaglutide (Novo Nordisks...
FDA accepts for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous infusion of liquid l...
FDA releases the form FDA-483 with seven observations from a January inspection at Chinas Zhejiang Huahai Pharmaceuticals.
