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Home » Topics » Regulatory

Regulatory
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Xolair approved in Europe for chronic spontaneous urticaria

March 7, 2014

Application for approval of an oral disintegrating tablet formulation

Feb. 27, 2014

European approval for Mirvaso for facial erythema of rosacea

Feb. 26, 2014

NeuraCeq obtains E.U. approval for PET imaging of beta-amyloid neuritic plaque density

Feb. 25, 2014

FDA extends approval of Kalydeco for cystic fibrosis mutations

Feb. 24, 2014

FDA approves BioMarin's Vimizim for MPS IVA

Feb. 17, 2014

Pharmacyclics gains FDA approval for use of Imbruvica in new indication

Feb. 13, 2014

Vanda's Hetlioz becomes first FDA-approved treatment for non-24-hour sleep-wake disorder

Feb. 3, 2014

AstraZeneca and BMS gain E.U. approval for Xigduo in type 2 diabetes

Jan. 22, 2014

Torii's sublingual immunotherapy drug for Japanese cedar pollinosis approved in Japan

Jan. 17, 2014
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