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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for TherOxs PMA for the TherOx ...[ Price : $8.95]
FDA warns San Diego, CA-based Green Wave Analytical about CGMP and other violations in its work as a contract testing laboratory f...[ Price : $8.95]
FDA grants priority review for a Sanofi BLA for efanesoctocog alfa to treat hemophilia A.[ Price : $8.95]
Federal Register notice: FDA announces that Eli Lilly used a priority review voucher for the approval of its NDA for Mounjaro (tir...[ Price : $8.95]
Federal Register notice: FDA announces an Emergency Use Authorization issued 7/13 to Novavax, Inc. for its Novavax Covid19 Vaccine...[ Price : $8.95]
Medical device cybersecurity consulting firm MedCrypt hires former CDRH Diabetes Diagnostics Device Branch lead reviewer Naomi Sch...[ Price : $8.95]
FDA clears a BrainsWay 510(k) for its Deep TMS H7 Coil for use in treating adults suffering from major depressive disorder and dep...[ Price : $8.95]
The state of Florida files a lawsuit against FDA for failing to timely respond to a state-sought Freedom of Information Act reques...