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U.S. FDA Grants Priority Review to Janssen’s New Drug...

Janssen Pharmaceuticals, Inc announced that the U.S. FDA has granted Priority Review designation for the NDA for a 500mg chewable tablet formulation of mebendazole.  If...

Amgen And Daiichi Sankyo Announce Agreement To Commercialize Biosimilars...

Amgen and Daiichi Sankyo Company, Limited announced the execution of an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in...

Sandoz Biosimilar Etanercept Recommended By US FDA For Approval...

Sandoz, a Novartis division and leader in biosimilars, announced that the US FDA Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted...

AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for...

AbbVie a global biopharmaceutical company, announced that the U.S. FDA granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the...

Mylan NV Launches Generic Temodar Capsules

Mylan N.V. announced the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is a...

EC Grants Marketing Authorization for Gilead’s Epclusa for the...

Gilead Sciences, Inc announced that the European Commission has granted marketing authorization for Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen...

Sanofi and WRAIR sign research agreement to co-develop Zika...

Sanofi and its vaccines global business unit Sanofi Pasteur Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development...

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