On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and ...

After an FDA rejection of its spinocerebellar ataxia (SCA) therapy, Biohaven was forced to rethink its strategy—cutting R&D spend by 60% and channeling the spirit of a scrappy startup again as it ...

(RTTNews) - NRx Pharmaceuticals, Inc. (NRXP) announced that it has completed a Type C guidance meeting with the U.S. FDA, receiving oral feedback that outlines a path to filing a New Drug Application ...

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