FDA warns San Diego, CA-based Green Wave Analytical about CGMP and other violations in its work as a contract testing laboratory for drug products and...
FDA grants priority review for a Sanofi BLA for efanesoctocog alfa to treat hemophilia A.
Federal Register notice: FDA announces that Eli Lilly used a priority review voucher for the approval of its NDA for Mounjaro (tirzepatide), a once-we...
Federal Register notice: FDA announces an Emergency Use Authorization issued 7/13 to Novavax, Inc. for its Novavax Covid19 Vaccine.
Medical device cybersecurity consulting firm MedCrypt hires former CDRH Diabetes Diagnostics Device Branch lead reviewer Naomi Schwartz as the firms n...
FDA clears a BrainsWay 510(k) for its Deep TMS H7 Coil for use in treating adults suffering from major depressive disorder and depression.
The state of Florida files a lawsuit against FDA for failing to timely respond to a state-sought Freedom of Information Act request seeking informatio...
Federal Register notice: FDA posts two draft guidances entitled Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development....
