Gilead Sciences Inc
6 products tracked · names used in filings: Gilead Sciences Inc, Gilead Sciences, Inc., Gilead Sciences International Ltd, Gilead Sciences International Limited
Upcoming milestones
anito-cel: PDUFA target action date (4L+ relapsed or refractory multiple myeloma)
Gilead Sciences, Inc. (GILD); anitocabtagene autoleucel; BLA; status: set; "…Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026."; filed 2026-05-07 · source
Recent milestones
FDA approves Bixlenvo (bictegravir sodium, lenacapavir sodium): new combination
Gilead Sciences Inc; NDA221104; New combination, Priority review; tablet · source
FDA approves Bixlenvo Sunlenca Starter Pack (Copackaged) (bictegravir sodium, lenacapavir sodium, lenacapavir sodium): new combination
Gilead Sciences Inc; NDA221443; New combination; tablet · source
BIC/LEN: PDUFA target action date (virologically suppressed people with HIV)
Gilead Sciences, Inc. (GILD); bictegravir and lenacapavir; NDA; status: set; "Food and Drug Administration (“FDA”) accepted New Drug Application for bictegravir and lenacapavir (“BIC/LEN”) for virologically suppressed people with HIV under priority review, with a Prescription Drug User Fee Act (“PDUFA”) target action date of August 27, 2026."; filed 2026-05-07 · source
FDA approves Hepcludex (bulevirtide-gmod), a new medicine
Gilead Sciences Inc; BLA761468; New biologic, Priority review; injection · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇺🇸 | Bixlenvo bictegravir sodium, lenacapavir sodium | Approved | 2026-08-27 |
| 🇺🇸 | Bixlenvo Sunlenca Starter Pack (Copackaged) bictegravir sodium, lenacapavir sodium, lenacapavir sodium | Approved | 2026-08-27 |
| 🇺🇸 | Hepcludex bulevirtide-gmod | Approved | 2026-05-22 |
| 🇪🇺 | Vitekta elvitegravir | Withdrawn | 2013-11-13 |
| 🇪🇺 | Eviplera emtricitabine;rilpivirine;tenofovir disoproxil | Authorised | 2011-11-27 |
| 🇪🇺 | Vistide cidofovir | Withdrawn | 1997-04-23 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.