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Intercept Pharma’s Liver Drug Wins Accelerated Approval by the FDA

FDA granted accelerated approval to Ocaliva, the first new medicine for primary biliary cholangitis in nearly 20 years.

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FDA Approves Once-Monthly MS Drug Zinbryta

A once-per-month injection for MS developed by Biogen and AbbVie received FDA approval.

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EU approves first gene therapy for children

The world’s first life-saving gene therapy for children, developed by GlaxoSmithKline and Italian scientists, was approved for sale in Europe.

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FDA Approves First Implantable Device for Opioid Dependency

Titan Pharmaceuticals announced that the U.S. FDA approved Probuphine (buprenorphine) implant for long-term maintenance of opioid dependence.

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FDA Approves First New Bladder Cancer Drug in 30 Years

FDA gave Tecentriq accelerated approval to treat specific types of advanced bladder cancer.

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Roche receives FDA Approval for novel PD-L1 biomarker assay

The VENTANA PD-L1 (SP142) Assay was approved as a complementary diagnostic for Tecentriq immunotherapy.

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Vifor Fresenius Enters into Agreement for OPKO Health’s RAYALDEE

Vifor Fresenius Medical Care Renal Pharma obtains rights to commercialize RAYALDEE in Europe, Canada and certain other international markets; OPKO Health to receive up to $282 million in upfront and milestone payments, plus tiered double-digit royalties.

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U.S. approves first drug for psychosis linked to Parkinson’s

Acadia Pharmaceuticals Inc’s drug for psychosis linked to Parkinson’s disease was approved in the United States on Friday, becoming the first treatment for the condition to get a nod in the country. The U.S. Food and Drug Administration, however, asked Acadia to include a black-box warning, its strictest warning, on the drug’s label for an […]

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Gadavist approved as first contrast agent for MRA use of supra-aortic arteries

Bayer announced U.S. FDA approval of Gadavist (gadobutrol) injection for use with magnetic resonance angiography to evaluate known or suspected supra-aortic or renal artery disease.

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FDA approves Abiomed’s device to treat cardiac shocks

The U.S Food and Drug Administration approved Abiomed Inc’s heart pump to treat patients who suffer cardiac shock after heart attack or heart surgery, sending its shares up about 4 percent in extended trading. Cardiac shock is a life-threatening emergency condition where the heart is suddenly unable to pump enough blood and oxygen to support […]

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