Acetaminophen (Tylenol) update The United States (U.S.) Food and Drug Administration (FDA) announced the initiation of a safety label change for products containing acetaminophen (Tylenol, other...

This monthly approval update provides a review of newly approved specialty drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

Want more information on this topic and more from our KOLs? On June 15, 2025, Sarepta, the manufacturer of Elevidys, issued a press release that announced a safety update for Elevidys and steps to...

Pipeline (late-stage development) Name Manufacturer Route of administration Mechanism of action Proposed / studied indication Status DNL126 Denali Therapeutics  IV SGSH RT using ETVto deliver SGSH...