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FDA releases the establishment inspection report containing six observations from a 10/2020 inspection at Juno Therapeutics.[ Price : $8.95]
FDA reviewers question the adequacy of a single Phase 3 trial submitted to support a ChemoCentryx NDA for avacopan, indicated for ...[ Price : $8.95]
FDA clears a Genesis Software Innovations 510(k) for its PreView 3D Shoulder Arthroplasty Planning Software.[ Price : $8.95]
Former CDER Division of Cardiovascular and Renal Products deputy director Stephen Grant joins NDA Partners as an expert consultant...[ Price : $8.95]
FDA accepts for review an Amgen supplemental NDA for Otezla (apremilast) for treating adults with mild-to-moderate plaque psoriasi...[ Price : $8.95]
Sens. Marshall, Smith, and Cassidy introduce bipartisan legislation to enable FDA to develop a framework for using real-world evid...[ Price : $8.95]
Pfizer pauses enrollment in a registration-enabling Phase 2 study of elranatamab after FDA requested additional data on three case...[ Price : $8.95]
ViiV Healthcare begins a rolling NDA submission for cabotegravir, a long-acting, injectable drug for preventing HIV.