Legal and Regulatory


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The US Food and Drug Administration (FDA) has approved Merck’s PREVYMIS (letermovir) tablets for oral use and injection...

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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...

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Symbiomix, a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections, today announced submission of a...