Press Releases
U.S. FDA Grants Priority Review to Janssen’s New Drug Application for Chewable Mebendazole Tablets
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...
Press Releases
Amgen And Daiichi Sankyo Announce Agreement To Commercialize Biosimilars In Japan
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...
Press Releases
Sandoz Biosimilar Etanercept Recommended By US FDA For Approval To Treat Multiple Inflammatory Diseases
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...
Press Releases
AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for Investigational ABT-414
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...
Press Releases
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...
Press Releases
EC Grants Marketing Authorization for Gilead’s Epclusa for the Treatment of All Genotypes of Chronic Hepatitis C
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...
Press Releases
Sanofi and WRAIR sign research agreement to co-develop Zika vaccine candidate
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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