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).
Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the US Food and Drug Administration (FDA) for two more indications in head and neck cancer.
Roche’s subsidiary Genentech has secured accelerated approval from the US Food and Drug Administration (FDA) for Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of diffuse large B-cell lymphoma (DLBCL).
Clinical-stage ophthalmology firm Acucela has secured orphan designation from the European Medicines Agency (EMA) for its emixustat hydrochloride to treat Stargardt disease.
Reata Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the US Food and Drug Administration (FDA) has granted orphan drug designation to bardoxolone methyl (bardoxolone) for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for its Emgality (galcanezumab-gnlm) injection (300mg) to treat episodic cluster headache in adults.
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