The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Roche's Xolair (omalizumab) for the prevention of severe allergic reactions after accidental exposure to one or more foods in people with allergies.
Alnylam Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its RNA interference (RNAi) therapeutic, Onpattro (patisiran) lipid complex injection, to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.
AstraZeneca has agreed to pay $110m to settle Texas drugs lawsuit claims of fraudulently marketing Seroquel and Crestor.
BioCryst Pharmaceuticals’ plasma kallikrein inhibitor BCX7353 has been given fast track designation by the US Food and Drug Administration (FDA) for the prevention of angioedema attacks in patients having hereditary angioedema (HAE).
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).
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