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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 epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse...
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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 for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection....
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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 of a Zika vaccine candidate. Â Â According to the terms of...
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FDA Approves Gilead’s Epclusa for the Treatment of All Genotypes of Chronic Hepatitis C
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...
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Novartis’ midostaurin achieves 60% response rate in advanced systemic mastocytosis
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...
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Merck, Premier Inc collaborate to improve care for osteoporosis patients
Merck and Premier Inc , a leading healthcare improvement company, have agreed to collaborate on the co-development of solutions to help improve population health. Initially, the companies will focus on reducing fracture rates for at-risk osteoporosis patients. ...
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EU approves Astrazeneca Plc’s New Antibiotic Zavicefta
AstraZeneca announced that the EC has granted marketing authorisation for Zavicefta , a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation. The approval includes intravenous use of Zavicefta for...
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