Keyword: Food and Drug Administration (FDA)

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SEC Investigates Valeant Again

03.03.2016 - Canada-based, US-managed drug firm Valeant Pharmaceuticals has confirmed it is under another investigation by the Securities and Exchange Commission (SEC), the latest in a string...

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US Law Firm Probes Dr. Reddy’s and PTC

02.03.2016 - US law firm Zeldes Haeggquist & Eck has started investigating a possible violation of federal securities laws by Indian generics manufacturer Dr. Reddy’s Laboratories and US...

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Recipharm Acquires Italy’s Mitim

26.02.2016 - Swedish drug developer and toll manufacturer Recipharm has acquired Italian contract company Mitim for €68 million. The acquisition of the family-owned firm, which is located in...

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FDA Accepts Sanofi’s Diabetes Drug as NDA

23.02.2016 - The US Food and Drug Administration (FDA) has accepted Sanofi’s New Drug Application (NDA) for the French drugmaker’s investigational fixed-ratio combination of basal insulin...

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Breakthrough Drug Status for Roche and AstraZeneca

19.02.2016 - Major drug makers Roche and AstraZeneca have been granted breakthrough therapy designations (BTD) by the US Food and Drug Administration (FDA) for treatments in multiple sclerosis...

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FDA Won’t Widen US Merck's Zetia, Vytorin Use

19.02.2016 - By a vote of ten to five, an advisory panel of the US Food and Drug Administration (FDA) has rejected an application by Merck & Co of the US to widen the indication of its...

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Clariant Starts Building Masterbatch Plant in Saudi Arabia

17.02.2016 - Construction work has started in Saudi Arabia on a new masterbatch plant for Swiss specialty chemicals producer Clariant. The facility in Yanbu will focus on the production of...

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AstraZeneca Cancer Drug Breakthrough

10.02.2016 - The combination of two cancer drugs from UK-Swedish drugs maker AstraZeneca and its biologics research and development arm MedImmune could be a potential breakthrough in treating a...