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FDA Puts Gilead’s HIV Combo Trials on HoldGilead
HIV
FDAThe FDA has paused five Gilead HIV combo trials over safety concerns, but the decision does not impact lenacapavir's upcoming PrEP approval. Gilead remains confident in its HIV pipeline and future plans.
FDA Narrows Use of PD-1 Drugs in GI CancersFDA
PD-1The FDA has restricted Merck’s Keytruda and BMS’s Opdivo for use only in PD-L1-positive gastric, GEJ, and esophageal cancers, citing limited benefit in PD-L1-negative patients based on recent trial data.
Merck Advances Oral PCSK9 Inhibitor with Phase 3 SuccessMerckMerck achieves successful phase 3 trial results for enlicitide, an oral PCSK9 inhibitor, showing significant cholesterol reduction and a strong safety profile, advancing toward potential 2027 approval.
Kennedy Overhauls CDC Vaccine CommitteeHHS
VaccineHHS Secretary Robert F. Kennedy Jr. has disbanded the CDC’s vaccine advisory panel, citing conflicts of interest. The sweeping changes raise concerns across the healthcare and pharmaceutical industries.
Avidity's FSHD Drug Gains FDA SupportAvidity
FDAAvidity Biosciences' siRNA therapy delpacibart braxlosiran shows promise in treating FSHD, gaining FDA support for accelerated approval and advancing to Phase III trials.
