Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

Cancer drugs that received accelerated approval from the FDA gained regular approval significantly faster if their ...

The notion that we can simultaneously demand expedited approvals while gutting the agency is misguided.

Following massive layoffs and cuts at the FDA, Makary’s plan for the agency is yet to fully unfold. But he has hinted at what ...

Sangamo Therapeutics Announces Important Derisking Milestones in Pathway to Anticipated BLA Submission for ST-920 in Fabry Disease ...

The US FDA has confirmed proteinuria as an acceptable primary endpoint in Dimerix ‘s Phase III ACTION3 trial of DMX-200 for ...

Accelerated drug development and approval pathways ... including the 2015 “Opinions on the Reform of Review and Approval Process for Drugs and Medical Devices,” and the 2020 revision of ...

There may be “substantial delays” between when a drug is granted accelerated approval for a cancer indication, when negative trial results are released, and when the accelerated approval of the drug ...