Tags : Clinuvel

Insights+: The US FDA New Drug Approvals in September and

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year’s record of approvals. However, there is a significant […]Read More

Clinuvel’s Scenesse Receives the US FDA’s Approval for Erythropoietic Protoporphyria

Shots: Scenesse (afamelanotide 16mg) is a drug developed for the treatment of rare genetic metabolic disorder and is approved to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) In 2018, Scenesse also received European Medicines Agency’s as an orphan medicinal product, approval for EPP and is […]Read More