The FDA has granted Regenerative Medicine Advanced Therapy designation to NouvNeu001, a cell therapy for Parkinson’s disease. NouvNeu001, developed by iRegene, is the first allogeneic cell therapy ...
The FDA has delayed reviews of two drugs in the Trump administration's fast-track program due to safety concerns, including a patient's death. The agency's reassessment raises questions about the ...
VTx-002, a gene therapy for ALS, received FDA fast-track designation. It targets and clears toxic TDP-43 protein clumps, a hallmark of ALS. A Phase 1/2 clinical trial (PIONEER-ALS) is evaluating its ...
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P.
Enolen's fast track designation by the FDA aims to expedite its development for localized prostate cancer treatment, addressing unmet medical needs. The localized delivery technology targets ...
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