The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the ...
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The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an ...
Gene therapy company uniQure N.V. (QURE) announced Tuesday that the company reached agreement with the U.S. Food and Drug ...
FDA recommends that Clene leverage additional Neurofilament Light (NfL) data from its three Expanded Access Protocols (EAPs) and the HEALEY ALS ...
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...
The US Food and Drug Administration (FDA) has published new draft guidance for its Accelerated Approval Program, which provides a process for expediting new drugs that serve unmet medical needs ...
The use of accelerated approval will continue to be a balancing act, due in part to demand for newer agents, said Ravi Bhatia ...
Merus’ Bizengri (zenocutuzumab-zbco) has received accelerated approval from the US Food and Drug Administration (FDA), ...
GlobalData on MSN2d
FDA shares new draft guidance for accelerated approvalThe new FDA guidance outlines how surrogate or intermediate clinical endpoints can support accelerated approval.
Patients should be selected for treatment based on the presence of an NRG1 gene fusion in tumor specimens.
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