FDA clears a Baxter International 510(k) for its next-generation Artificial Kidney 98 (AK 98) dialysis machine, which is designed to be a portable sys...
Boehringer Ingelheim discontinues a Phase 2 trial of a first-in-class compound for reducing the risk or severity of acute respiratory distress syndrom...
FDA acting commissioner Janet Woodcock discusses two lessons learned about clinical research from the Covid-19 pandemic.
FDA extends the PDUFA review date for Kadmons belumosudil for three months to review additional information submitted by the company.
Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Marketing 21 CFR Part 203.
Federal Register notice: FDA issues a priority review voucher to Origin Biosciences after it gained approval for a qualified rare pediatric disease pr...
FDA approves an Aveo Oncology NDA for Fotivda (tivozanib) for treating adults with relapsed or refractory advanced renal cell carcinoma who have recei...
FDA announces a three-day Oncologic Drugs Advisory Committee meeting to discuss the continued approval of six indications associated with three monocl...