USFDA

The U.S. Food and Drug Administration approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

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The US Food and Drug Administration (FDA) has granted rare paediatric disease designation to ArmaGen Inc's AGT-181, a potential treatment for patients with Hurler syndrome, a disease that is also known as mucopolysaccharidosis type I (MPS I).

Espero Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for GoNitro for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

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Merck & Co's drug to reverse the effects of muscle relaxants used in surgery is safe and effective enough to warrant approval, an independent panel to the U.S. Food and Drug Administration said. The drug, which goes by the chemical name of sugammadex, has repeatedly been rejected by the FDA due to concerns about potentially dangerous allergic reactions, even though it is approved in more than 75 countries.

GlaxoSmithKline plc  received approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nucala® (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.
Melanoma, the most aggressive type of skin cancer, is the leading cause of death from skin cancer. Patients with stage III melanoma are generally treated by surgery to remove the melanoma skin lesions and the nearby lymph nodes.

The US Food and Drug Administration (FDA) has cleared Turing Pharmaceuticals AG's Investigational New Drug (IND) application for TUR-004 in the treatment of epileptic encephalopathies. In addition, TUR-004 has been granted Fast Track designation.

Lupin Pharmaceuticals Inc, a subsidiary of the company, has launched calcium acetate capsules having received final approval from the US health regulator. The drug is indicated for the control of hyperphosphatemia in end stage renal failure.

Endo Pharmaceuticals Inc., a subsidiary of Endo International plc, and BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Belbuca (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.