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 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, 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 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).
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.
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 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 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.
The US Food and Drug Administration (FDA) has extended approval for Novo Nordisk’s Victoza (liraglutide) injection for type 2 diabetes in paediatric patients, aged 10 years or older.
Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Kanjinti (trastuzumab-anns), a biosimilar to Roche’s Herceptin (trastuzumab).
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.