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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 sets May 1 decision date for uniQure's Huntington's disease gene therapy after year-long regulatory sagaThe U.S. Food and Drug Administration has accepted uniQure's biologics license application for its Huntington's disease gene therapy and placed it on the priority review track, with a May 1 target…