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FDA declines to grant Ocugen an emergency use authorization for Covaxin for active immunization to prevent Covid-19 in individuals...[ Price : $8.95]
Federal Register notice: FDA issues an order to debar Patrick Charles Bishop for a period of five years from importing or offering...[ Price : $8.95]
Sanofi petitions FDA to mandate a labeling change to Seqirus influenza vaccine products Fluad and Fluad Quadrivalent to reflect th...[ Price : $8.95]
A CDER online post updates the Centers efforts to support rare disease drug development, particularly through data sharing initiat...[ Price : $8.95]
FDA issues South Korea-based GC Pharma a complete response letter on its BLA for GC5107 (immune globulin intravenous (human), 10% ...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpar...[ Price : $8.95]
Federal Register notice: FDA debars George Kuiper for a period of five years from importing or offering for import any drug into t...[ Price : $8.95]
FDA grants DexCom a breakthrough device designation for its Dexcom real-time continuous glucose monitoring system for use in the h...