USFDA

The prospect of a major change to the regulatory agency comes as drug makers are under fire for high prices, including Marathon Pharmaceuticals LLC, which said  "stop" the launch of its drug Duchenne muscular dystrophy after American lawmakers questioned her $ 89,000 a year award.

President Trump promised to review the Food and Drug Administration could make major changes, including steps to accelerate the approval process of new prescription drugs, setting up a shock with critics who say its push for the Deregulation could put consumers at risk.

uniQure N.V. announced that AMT-060,  its proprietary, investigational gene therapy in patients with severe hemophilia B, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).  This designation is based on results from the ongoing, dose-ranging Phase 1-2 study that show sustained increases in Factor IX (FIX), reductions in FIX replacement usage and a near cessation of spontaneous bleeding in patients with severe disease at up to 12 months follow-up. 

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VBX Stent Graft has received U.S. Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. This marks the availability of the only balloon expandable stent graft with an indication for the iliac artery.

Ironwood Pharmaceuticals, Inc. and Allergan plc  announced  that the U.S. Food and Drug Administration (FDA) has approved a 72 mcg dose of LINZESS®(linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients.

Sunovion Pharmaceuticals Inc. (Sunovion)  announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Latuda® (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years. LATUDA is also approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

Opiant Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration has approved the 2mg formulation of NARCAN® Nasal Spray for opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. NARCAN® is partnered with and marketed in the U.S. by privately-held Adapt Pharma. 

DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER® and EXPEDIUM®Fenestrated Screw Systems. When used in conjunction with CONFIDENCETM High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery.

The US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for AstraZeneca's Symbicort (budesonide/formoterol) inhalation Aerosol.The FDA’s decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to a Written Request (a prerequisite for qualifying for paediatric exclusivity under Section 505A of the Federal Food, Drug, and Cosmetic Act). Symbicort is currently approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults.