Federal Register notice: FDA releases two final guidances on drug interaction studies.
Federal Register notice: FDA issues a priority review voucher for the approval of a rare pediatric disease product application Sarepta Therapeutics V...
Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Levonorgestrel.
FDA posts a final guidance on Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biolo...
Federal Register notice: FDA announces a 2/26 Oncologic Drugs Advisory Committee meeting that will discuss a Steba Biotech NDA for prostate cancer and...
FDA seeks outside groups or individual data scientists to develop computational algorithms to identify adverse event anomalies in open FDA adverse eve...
FDA grants accelerated approval for Epizymes Tazverik (tazemetostat) for adults and pediatric patients aged 16 years and older with metastatic or loca...
FDA approves an expanded indication for Abbotts Infinity Deep Brain Stimulation system to include targeting of an area of the brain called the interna...