Keyword: Food and Drug Administration (FDA)

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FDA Approves Mylan’s Yasmin Copies

11.09.2015 - Following approval from the US Food and Drug Administration (FDA), Netherlands-domiciled Mylan has launched generic copies of Bayer's drospirenone and ethinyl estradiol-based...

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US Food Safety Group Sues Department of Agriculture for Withheld GMO Information

09.09.2015 - US food safety advocate group Center for Food Safety (CFS) has sued the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), charging that it...

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FDA Releases Naming Rules for Biosimilars

31.08.2015 - The US Food and Drug Administration has released a proposal for naming biosimilars – lower-cost biotech drugs – almost simultaneously with the market launch of the first such...

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Amgen Gets Nod for New Cholesterol Drug

31.08.2015 - Amgen has won US Food and Drug Administration (FDA) approval for Repatha, the second medicine in a new class of biologics recently greenlighted by the agency and claimed to reduce...

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Valeant to Acquire Sprout and Enter Sexual Health Market

24.08.2015 - US specialty drugs company Valeant Pharmaceuticals has agreed to pay $1 billion in cash, on a debt-free basis, for female sexual heath firm Sprout Pharmaceuticals. Under the terms...

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United Therapeutics Sells Priority Review Voucher to AbbVie

21.08.2015 - US biotechnology company United Therapeutics has agreed to sell its Rare Pediatric Disease Priority Review Boucher (PPRV) to a subsidiary of biopharmaceutical firm AbbVie for $350...

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GSK Says Drugs from Closed Plant Safe

14.08.2015 - Drugs produced at a GlaxoSmithKline pharmaceutical plant in North Carolina closed earlier this week are safe, the company said, adding that production is due to restart by the...

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Novartis Can Sell Neupogen Copy in US in September

24.07.2015 - A US federal appeals court has ruled that Swiss drugmaker Novartis can begin selling Zarxio, its lower-cost generic version of an Amgen drug, on the US market starting in September...