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Upcoming Infectious Disease & Vaccines FDA decisions & readouts

Updated ยทnext FDA decision on the calendar
PDUFA target dates and trial readouts in infectious disease & vaccines, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
Cancer & OncologyObesity & MetabolicCNS & NeurologyImmunology & InflammationCardiovascularRare DiseaseHematologyOphthalmology & Eye

PDUFA decisions (2)

GSK · 2026-10-26
Bepirovirsen - (B-Well): Chronic hepatitis B
GILD · 2027-02-02
Yeztugo (lenacapavir) once-weekly oral: HIV pre-exposure prophylaxis (PrEP)

Trial readouts (9)

AVIR · Sep 2026 (est.)
Bemnifosbuvir-Ruzasvir
VIR · Nov 2026 (est.)
Bulevirtide
AVIR · Dec 2026 (est.)
Bemnifosbuvir-Ruzasvir
TRAW · Dec 2026 (est.)
rigosertib
VIR · Dec 2026 (est.)
Tobevibart
COGT · Mar 2027 (est.)
CGT9486
CHRS · Sep 2027 (est.)
CHS-1420
IVA · Sep 2027 (est.)
IVA337
MRK · Oct 2027 (est.)
MK-8527

Every upcoming FDA decision date, all therapeutic areas, on the 2026 PDUFA calendar · all conditions

We don't show an approval percentage for these infectious disease & vaccines catalysts: here's why.