The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Alnylam Pharmaceuticals’ patisiran, an investigational RNAi therapeutic for the treatment of hATTR amyloidosis, a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).
The European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor which is being developed by AstraZeneca and Merck to treat neurofibromatosis type 1 (NF1).
Pfizer has secured approval from the European Commission (EC) for its Xeljanz (tofacitinib citrate) for the treatment of moderately to severely active ulcerative colitis (UC).
Novelion Therapeutics has secured marketing authorization from the European Commission (EC) for Myalepta (metreleptin) to treat generalized and partial lipodystrophy.
Progenics Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its radiotherapeutic drug Azedra (iobenguane I 131) to treat rare tumors of the adrenal gland (pheochromocytoma or paraganglioma).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted positive opinion for the approval of AstraZeneca’s Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 on ≥1% of tumor cells and whose disease has not progressed after platinum-based chemotherapy and radiation therapy (CRT).
Novartis division Sandoz has secured marketing authorization from the European Commission (EC) for its biosimilar Hyrimoz (adalimumab) for use in all same indications as reference medicine including rheumatology, gastroenterology and dermatology.
Indivior announced that the US Food and Drug Administration (FDA) has approved Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults.
The Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted against recommending GlaxoSmithKline’s (GSK) mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.
Agios Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Tibsovo (ivosidenib) to treat adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.
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