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CDERs Office of Prescription Drug Promotion proposes to conduct a study entitled Accelerated Approval Disclosures on Direct-to-Con...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a Secura Bio NDA for Farydak (panobinostat) capsules after the company requeste...[ Price : $8.95]
CDRH director Jeffrey Shuren says legislation is needed to provide more regulatory flexibility and agility to deal with artificial...[ Price : $8.95]
Former CBER Office of Vaccines Research and Review deputy director Philip Krause joins Mesoblasts board of directors and will assi...[ Price : $8.95]
FDA grants a second breakthrough designation to Pfizers respiratory syncytial virus vaccine candidate, this time to prevent lower ...[ Price : $8.95]
FDA approves a label update for Janssens Cabenuva to permit starting the injection treatment without an oral treatment lead-in.[ Price : $8.95]
FDA sends Eli Lilly and Innovent Biologics a complete response letter on its BLA for sintilimab injection, a me-too PD-1 inhibitor...[ Price : $8.95]
FDA announces the dates and program for the Generic Drugs Forum 2022.