The Department of Justice petitions the U.S. Supreme Court asking it to reverse last months decision by the Fifth Circuit Court of Appeals that would ...
FDA gives the green light for updated Covid-19 vaccines manufactured by ModernaTX and Pfizer that are formulated to more closely target currently circ...
AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy in lung cancer patients extended median prog...
FDA and Duke-Margolis Center for Health Policy announce a 9/18-19 two-day public workshop to discuss pregnancy safety studies.
Federal Register notice: FDA seeks participation by industry organizations in selecting nonvoting industry representatives to serve on the Vaccines an...
Federal Register notice: FDA makes available a final guidance entitled Institutional Review Board (IRB) Review of Individual Patient Expanded Access S...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Peptide Drug Products.
Federal Register notice: FDA announces an opportunity to participate in its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pil...
