FDA Approvals

GlaxoSmithKline plc announced that it has received Breakthrough Therapy Designation from the U.S. FDA for its meningitis B vaccine Bexsero for the development...

BioProtect begins study of ProSpace biodegradable spacer to protect rectum, lower GI tract during radiation therapy

FDA Approvals

BioProtect, the technology leader in biodegradable balloon spacers protecting normal tissue during radiation therapy, announced the launch of its clinical trial following Investigational Device...

Novo Nordisk Receives FDA Approval Of OZEMPIC® (Semaglutide) Injection For The Treatment Of Adults With Type 2 Diabetes

FDA Approvals

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for OZEMPIC® (semaglutide) injection 0.5 mg or...

Sunovion Receives FDA Approval for Lonhala™ Magnair™ Inhalation Solution to Treat COPD

FDA Approvals

Sunovion Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution...

Merck’s Mavenclad (Cladribine Tablets) Approved for Relapsing-Remitting Multiple Sclerosis in Canada

FDA Approvals

Merck, a leading science and technology company, today announced that Health Canada has approved MAVENCLAD™ (Cladribine Tablets) as monotherapy for the treatment of adult...

FDA Approves Amgen’s Repatha® (evolocumab) To Prevent Heart Attack And Stroke

FDA Approvals

Amgen announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the...

FDA grants orphan drug status to Shire’s UC treatment SHP647

FDA Approvals

The US Food and Drug Administration (FDA) has granted orphan drug designation to Shire’s investigational mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antibody, SHP647, for...

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