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Indian regulators have approved a generic version of Gilead’s hepatitis C drug Harvoni (ledipasvir-sofosbuvir) in a country with the highest infection rate on the planet. Read More
The FDA has granted orphan drug and rare pediatric disease designations to ARMGO Pharma’s ARM210 for the treatment of Duchenne Muscular Dystrophy. Read More
The FDA has blessed a new treatment for the bleeding disorder von Willebrand disease. The FDA disclosed Tuesday that it has approved California drugmaker Baxalta’s Vonvendi (recombinant von Willebrand factor) for on-demand treatment of adult patients with the inherited disorder. Read More
The FDA approved Alexion Pharmaceuticals’enzyme replacement drug Kanuma for an ultra rare disorder known as lysosomal acid lipase deficiency in pediatric and adult patients. Read More
Two months into the new federal fiscal year, generic approvals are faring considerably better compared to the same year-ago time frame, according to the FDA’s Generic Drug Program database. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has given its blessing to AstraZeneca's Tagrisso as part of the Early Access to Medicines Scheme. Read More