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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novo Nordisks Ozempic.[ Price : $8.95]
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Mercks anti-PD-1 therapy as monotherapy for...[ Price : $8.95]
FDAs Office of New Drugs denies a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for diabetes drug ...[ Price : $8.95]
Former FDA commissioner Frank Young dies at age 88.[ Price : $8.95]
Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for co...[ Price : $8.95]
FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Clinical Immunogenicity Considerations for Biosimilar and I...[ Price : $8.95]
FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tub...