FDA starts kicks off review of Gilead's weekly HIV pill

FDA starts kicks off review of Gilead's weekly HIV pill

The FDA is due to deliver a verdict in February on Gilead's once-weekly pill for HIV PrEP, which could expand the options available to patients.

FDA Reviews Gilead’s Once-Weekly Oral Lenacapavir for HIV Prevention

As reported on Business Wire, Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application for a 300‑mg oral formulation of lenacapavir (Yeztugo) as a once-weekly option for HIV pre-exposure prophylaxis (PrEP). The regulatory agency has assigned a target decision date of February 2, 2027 under […]

Lilly buys another pain biotech; FDA sets decision for once-weekly PrEP pill

Plus, news about Merck, MultiValent Biotherapies, Alvotech, enGene, Mirum, and Adaptive Biotechnologies. 💸 Eli Lilly acquires another pain biotech: The Indianapolis pharma giant has made its 11th acquisition of the year, snapping up Austin, TX-based ...