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US Congress

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ViiV’s Tivicay for HIV on course for EU approval

More positive news for GSK, Pfizer and Shionogi joint venture

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Nexavar cleared for thyroid cancer by FDA

Bayer and Onyx win expansion of oncology drug’s use in US

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New FDA guidance for advertising

Clarifies circumstances when drug names need to be mentioned

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FDA turns down Forest/Gedeon Richter’s antipsychotic

US regulator wants more information for cariprazine

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AZ drug for opioid constipation starts FDA review

Naloxegol on course to compete with Takeda’s Amitiza

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Teva withdraws US filing for cancer biologic

FDA requests more data for balugrastim

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FDA clears J&J’s breakthrough lymphoma therapy

Imbruvica approved to treat mantle cell lymphoma

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Sarepta slumps as FDA questions muscular dystrophy drug

US regulator casts doubt on biomarker for eteplirsen

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UCB files Vimpat for expanded epilepsy use

Submits monotherapy application to FDA


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FDA clears Roche’s breakthrough drug Gazyva

First drug approved in US under new scheme

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FDA suspends sale of Ariad’s cancer drug

Iclusig linked to increased risk of blood clots

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FDA creates drug shortage plan

Manufacturers required to give early notice of potential shortfall of important medicines

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