FDA accepts for priority review a Servier supplemental NDA for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untr...
Federal Register notice: FDA updates is listing of guidance documents related to the Covid19 public health emergency.
Federal Register notice: FDA revokes the Emergency Use Authorizations (EUAs) issued to Bio-Rad Laboratories for the BioPlex 2200SARSCoV2 IgG, and Quot...
A Phase 3 study evaluating Gileads Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2-metastatic breast cancer shows that the therapy met...
FDA places a partial clinical hold on an Alpine Immune Sciences trial evaluating davoceticept in combination with pembrolizumab (Mercks Keytruda) in a...
House Energy and Commerce Committee chairman Frank Pallone (D-NJ) introduces the Accelerated Approval Integrity Act that would revamp FDAs accelerated...
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) 360 mg (injection for intravenous use) five days after submitting an NDA for adult patients with...
FDA grants Merit Medical Systems a breakthrough device designation for its Embosphere Microspheres for use in genicular artery embolization procedures...