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US Congress

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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

- PMLiVE

FDA creates drug shortage plan

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

Novartis building

Novartis weighs in on biosimilar naming debate

Files petition urging FDA to keep system where biosimilars share a name with the original drug

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