GSK’s Nucala® (mepolizumab) receives approval from US FDA Issued: London UK – LSE Announcement First anti-IL5 treatment for adults and adolescents with severe asthma with an eosinophilic phenotype GlaxoSmithKline plc (LSE/NYSE: GSK) today received approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nucala® (mepolizumab) as an add-on […]
After months of speculation on who Pfizer Inc. (PFE) will attempt to buy are now officially over — sort of. It has been confirmed that Pfizer Inc. and Allergan Plc (AGN), according to the Wall Street Journal, are discussing a potential merger. The two companies have declined to comment. Analysts have been speculating on […]
U.S. health regulators on Tuesday approved Amgen Inc’s novel cancer immunotherapy for injection into melanoma lesions and lymph nodes of patients with the deadliest form of skin cancer that returns after initial surgery. The drug, to be sold under the brand name Imlygic, is an engineered version of a herpes virus that kills cancer cells […]
RIDGEFIELD, Conn., Oct. 16, 2015 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind® (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa® (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. […]
Thousand Oaks, Calif.-based Amgen (AMGN), faced with generic and biosimilars competition as its blockbusters lose patent protection, is fighting back on a number of fronts. On Oct. 2, 2015, Novartis (NVS) announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for its proposed biosimilar to Amgen’s Enbrel […]