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News List

Novartis could face legal action over Zolgensma application europeanpharmaceuticalreview
August 09, 2019
The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.
FDA to Review sBLA for Praluent americanpharmaceuticalreview
September 18, 2018
Regeneron Pharmaceuticals and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental...
FDA Takes Action to Address Epipen Shortages americanpharmaceuticalreview
August 24, 2018
The U.S. Food and Drug Administration (FDA) took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled