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drug approval

3 stories related to this topic, newest first.

FDA Issues Priority Vouchers to Three Companies for Psychedelic Medication ReviewsSubstrate placeholder — needs review · Wikimedia Commons (CC BY-SA 3.0)
world11 days agoDeveloping

FDA Issues Priority Vouchers to Three Companies for Psychedelic Medication Reviews

The Food and Drug Administration announced on April 24, 2026, that it is issuing national priority vouchers to three companies to fast-track reviews of psychedelic medications. The companies are studying psilocybin for depression and methylone for PTSD. The move follows President…

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FDA Rejects Cancer Drug Candidate Lifileucel on Second Attempt After Prior ReviewSubstrate placeholder — needs review · Wikimedia Commons (CC BY-SA 3.0)
science24 days ago

FDA Rejects Cancer Drug Candidate Lifileucel on Second Attempt After Prior Review

The U.S. Food and Drug Administration has rejected the cancer drug candidate lifileucel for the second time. The drug, developed by Iovance Biotherapeutics, targets advanced melanoma. This decision follows an earlier rejection in 2023 and involves issues with manufacturing and da…

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FDA Withdraws Approval for GSK's Leucovorin in Treating Cerebral Folate DeficiencyMaxwell Hamilton / Wikimedia (CC BY-SA 3.0)
science5 days ago

FDA Withdraws Approval for GSK's Leucovorin in Treating Cerebral Folate Deficiency

The U.S. Food and Drug Administration is withdrawing approval for GlaxoSmithKline's leucovorin as a treatment for cerebral folate deficiency, a rare brain disorder. GSK stated that the withdrawal was anticipated as part of the original approval plan. The disorder involves symptom…

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