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December 28, 2017
The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.
December 20, 2017
FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.
December 19, 2017
Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.
December 14, 2017
The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.
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The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.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.
December 11, 2017
FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.