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Federal Register notice: FDA determines the regulatory review period for Esperion Therapeutics Nexletol (bempedoic acid), indicate...[ Price : $8.95]
AdvaMed asks FDA to consider adding more information to a draft guidance on ethical considerations for clinical investigations of ...[ Price : $8.95]
Two stakeholders comment on an FDA draft guidance on computer software assurance.[ Price : $8.95]
FDA approves Seagens Adcetris (brentuximab vedotin) for treating pediatric patients with previously untreated high risk classical ...[ Price : $8.95]
FDA refuses to file a BrainStorm Cell Therapeutics BLA for its NurOwn to treat ALS.[ Price : $8.95]
Yale University researchers say FDA should strengthen its regulatory approach to artificial intelligence products used in breast c...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Sameness Evaluations in an ANDA Active Ingredients.[ Price : $8.95]
FDAs Pulmonary-Allergy Drugs Advisory Committee votes 16 to 1 to support approval of an AstraZeneca NDA for PT027 (albuterol/budes...