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FDA publishes a draft guidance with recommendations for 510(k) submissions for orthopedic non-spinal bone plate, screw, and washer devices.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...
The leadership of the House Energy and Commerce Committee and two of its subcommittees asks FDA for detailed drug shortage information about 10 specif...
