Regulation

FDA approves Alexion’s Soliris to treat adults with neuromyelitis optica spectrum disorder

Alexion Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Soliris to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

FDA grants fast track designation to empagliflozin to treat chronic heart failure

The US Food and Drug Administration (FDA) has granted fast track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced.

Regeneron, Sanofi get FDA nod for Dupixent to treat chronic rhinosinusitis with nasal polyps

Regeneron Pharmaceuticals and Sanofi have secured approval from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) to treat adults with nasal polyps accompanied by chronic rhinosinusitis.

Tesaro’s niraparib secures FDA priority review for late stage ovarian cancer

Tesaro, a GlaxoSmithKline (GSK) company, has secured priority review designation for its polymerase (PARP) inhibitor ZEJULA (niraparib) from the US Food and Drug Administration (FDA) for the treatment of late stage ovarian cancer.

Pfizer’s Talzenna gets EC nod for metastatic breast cancer treatment

Pfizer has secured approval from the European Commission (EC) for its Talzenna (talazoparib) to treat patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (MBC).

Allergan’s Botox secures FDA paediatric approval for upper limb spasticity

The US Food and Drug Administration (FDA) has expanded the approval of Allergan’s Botox (onabotulinumtoxinA) to cover the treatment of paediatric patients with upper limb spasticity.

Alexion gets FDA priority review for Ultomiris to treat atypical hemolytic uremic syndrome

The US Food and Drug Administration (FDA) has accepted Alexion Pharmaceuticals’ supplemental biologics licence application (sBLA) for priority review of Ultomiris to treat people with aHUS and inhibition of complement-mediated thrombotic microangiopathy (TMA).

AstraZeneca, Merck get EC nod for Lynparza to treat advanced ovarian cancer

AstraZeneca and Merck have secured approval from the European Commission (EC) for Lynparza (olaparib) as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer.

Roche gets Japanese approval for personalised medicine Rozlytrek

Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours.