FDA approves Emergent BioSolutions Narcan 4 mg naloxone hydrochloride nasal spray, the first nonprescription over-the-counter product for reversing th...
Janssen Pharmaceutical discontinues the development of an investigational respiratory syncytial virus adult vaccine and related Phase 3 study due to b...
Federal Register notice: FDA sends to OMB an information collection extension entitled Testing Communications by FDAs Center for Devices and Radiologi...
Two Ropes & Gray attorneys see signs that FDA may be shifting its approach to drug accelerated approvals.
FDA publishes a draft guidance with recommendations for 510(k) submissions for orthopedic non-spinal bone plate, screw, and washer devices.
The DC federal court orders FDA to give Vanda Pharmaceuticals information from its review of a Vanda sNDA for a new Hetlioz indication.
FDA warns Dallas, TX-based Cornea Associates about conducting clinical investigations without submitting a required IND.
Merck says it will meet with regulatory authorities about an expanded indication after reporting Phase 3 trial results of Keytruda in certain endometr...
