Press Releases

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 unanimously (20-0), in support of biosimilar etanercept for all five indications of the reference...

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 epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse...

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 generic version of Merck's Temodar®. Mylan received final approval from the U.S. Food and...

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 for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection....

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 of a Zika vaccine candidate.    According to the terms of...

Gilead Sciences, Inc. announced that the U.S. FDA has approved Epclusa , the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also...

Novartis announced that The New England Journal of Medicine published data for PKC412 demonstrating an overall response rate, defined as a major or partial response, of 60% (95% confidence interval , 49-70%; P<0.001) in patients with advanced systemic mastocytosis...