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...
FDA releases revisions to four sections of labeling for ViiVs Triumeq and Dovato.
A Parenteral Drug Association article explores how FDA is supporting advanced drug manufacturing techniques.