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December 14, 2017
FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.
The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.
December 13, 2017
The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.
December 12, 2017
The agency has posted a warning letter to companies promoting Coco Loko, a snortable chocolate powder, and Legal Lean, a drink, as substitutes for street drugs.
The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.
December 11, 2017
FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.
December 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
December 05, 2017
The agency and the European Commission published updated guidance to answer questions about Brexit.
During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.