News

FDA rejects Sunovion’s ADHD drug

FDA rejects Sunovion’s ADHD drug

Sunovion’s application to market dasotraline for the treatment of attention-deficit hyperactivity disorder (ADHD) has been rejected by US regulators.

Bayer wins US nod for Jivi

Bayer wins US nod for Jivi

US regulators have approved Bayer’s Jivi (formerly BAY94-9027), a longer-acting Factor VIII therapy designed to reduce the number of infusions necessary to prevent bleeds in patients with Haemophilia A.

Alnylam’s RNA therapy Onpattro bags EU nod

Alnylam’s RNA therapy Onpattro bags EU nod

Alnylam’s RNAi therapeutic Onpattro has been approved for use in Europe to treat Hereditary Transthyretin-Mediated (hATTR) Amyloidosis (hATTR amyloidosis) in adults with Stage 1 or Stage 2 polyneuropathy.

EU expands use of Amgen’s Blincyto

EU expands use of Amgen’s Blincyto

European regulators have expanded the scope of Amgen’s Blincyto to include the treatment of younger patients with a rare type of leukaemia.