FDA Orders REMS Modifications for iPLEDGE

FDA Orders REMS Modifications for iPLEDGE

Following a period of open comment, public advisory committee meetings, and closed-door deliberations, FDA is mandating changes to iPLEDGE, the Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin for acne. The Isotretinoin Product Manufacturers Group...
HS Treatment Update: FDA Approves New Indication for Cosentyx

HS Treatment Update: FDA Approves New Indication for Cosentyx

The FDA has approved Cosentyx® (secukinumab) from Novartis to treat moderate to severe hidradenitis suppurativa (HS) in adults. It is approved as a 300mg dose, administered every four weeks, with the option to increase to every two weeks if the patient has an...