Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
IDVYNSO (doravirine/islatravir) is a Merck & Co., Inc. program in adults with HIV-1 infection (treatment-naive; 96-week data in virologically suppressed adults). Its PDUFA date is Apr 22, 2027, the FDA's goal date to complete review of the application. 1 FDA decision on record below. Every date links its source.
Indication under review: Adults with HIV-1 infection (treatment-naive; 96-week data in virologically suppressed adults). Sponsor: Merck & Co., Inc. (MRK). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 1 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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Questions
When is IDVYNSO (doravirine/islatravir)'s next FDA decision or readout?
IDVYNSO (doravirine/islatravir)'s PDUFA date is Apr 22, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at IDVYNSO (doravirine/islatravir)'s most recent FDA decision?
On Apr 21, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is IDVYNSO (doravirine/islatravir) used for?
In our records IDVYNSO (doravirine/islatravir) is under review or in development for Adults with HIV-1 infection (treatment-naive; 96-week data in virologically suppressed adults).
Who makes IDVYNSO (doravirine/islatravir)?
Merck & Co., Inc. (MRK).
Has IDVYNSO (doravirine/islatravir) been approved by the FDA?
Yes. The FDA approved an application for IDVYNSO (doravirine/islatravir) on Apr 21, 2026; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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