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FDA places a partial clinical hold on a Nuvation Bio Phase 1 dose escalation study of NUV-422 in solid tumors after receiving repo...[ Price : $8.95]
FDAs Vaccines and Related Biological Products Advisory Committee meets to discuss whether and how the SARS-CoV-2 strain compositio...[ Price : $8.95]
A new CDER Office of New Drugs annual report highlights some of its work with sponsors to advance innovative clinical trial design...[ Price : $8.95]
FDA clears an Altamira Therapeutics 510(k) to market its nasal spray Bentrio for treating allergic rhinitis.[ Price : $8.95]
FDA clears an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of...[ Price : $8.95]
AbbVie submits an sNDA for Qulipta as a preventive treatment for chronic migraine.[ Price : $8.95]
Amryt seeks FDA formal dispute resolution over a complete response letter it received in February for its NDA for Filsuvez (oleoge...