Legal and Regulatory


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Europe`s medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due...

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India`s largest drug group Sun Pharmaceutical Industries said on Friday its US sales might fall this year because of pressure...

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The U.S. Food and Drug Administration on Thursday approved a drug made by Marathon Pharmaceuticals to treat Duchenne...

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Teva Pharmaceutical Industries Ltd., announced that it has filed an abbreviated new drug application (ANDA) with the U.S....

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Audentes Therapeutics’ investigational new drug (IND) application for AT342, its gene therapy product candidate, to treat Crigler-Najjar Syndrome...

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AstraZeneca announced that on 25 January 2017 the US Food and Drug Administration (FDA) granted six months of...

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Five Prime Therapeutics, Inc. announced that the European Commission has granted orphan designation for cabiralizumab (FPA008) for the...

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Ethypharm is pleased to announce today that it has signed a definitive agreement to acquire Martindale Pharma. Martindale...