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Merck says its oral PCSK9 inhibitor met all primary and secondary endpoints in the CORALreef Lipids Phase 3 trial.[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at the Las Vegas, NV-based AnazaoHealth compounding facili...[ Price : $8.95]
FDA policy and regulatory expert Steven Grossman warns that the agencys current trajectory risks undermining its effectiveness by ...[ Price : $8.95]
FDA warns Jackson, WI-based Wisconsin Pharmacal about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA agrees to accept a biosimilar application to compete with Johnson & Johnsons Stelara that does not include clinical efficacy s...[ Price : $8.95]
FDA clears a Medtronic 510(k) for its MiniMed 780G insulin delivery system to integrate with Abbotts Instinct continuous glucose m...[ Price : $8.95]
HHS says FDA is removing members of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and Childrens Hospita...[ Price : $8.95]
FDA warns Castle Rock, CO-based Compounders International Analytical Laboratory about CGMP violations and deviations in its work t...