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- FDA grants tentative approval for generic HIV prevention shot, boosting access in low-income nationsAfter months of anticipation, the U.S. Food and Drug Administration issued a tentative approval for Dr. Reddy’s Laboratories to produce a generic version of lenacapavir, the long‑acting injectable…
- FDA places uniQure’s Huntington’s gene therapy in priority review, targeting May 2027 approvalThe U.S. Food and Drug Administration has accepted uniQure’s filing for its Huntington’s disease gene therapy and placed the product under priority review, a step that could accelerate a decision b…