Three more drug companies comment on an FDA draft guidance on using real-world evidence and data in regulatory decision-making for drugs and biologics...
Revance Therapeutics refiles its BLA for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabellar lines, in response to ...
FDA warns Chinas Wickimed Medical Equipment Manufacturing Company about Quality System and Medical Device Reporting violations in its manufacture of s...
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...