WINREVAIR — PDUFA
Sep 21
FDA set PDUFA date of September 21, 2026.Source filing
MRK biotech catalysts & pipeline
MERCK & CO INC · Data as of 2026-09-08
Upcoming catalysts
WELIREG — PDUFA
Oct 4
FDA set PDUFA date of Oct. 4, 2026.Source filing
ifinatamab deruxtecan — PDUFA
Oct 10
The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of October 10, 2026.Source filing
Keytruda (pembrolizumab) — Regulatory decision
2027
Instead, Keytruda will now be eligible to be selected in 2027 for government price setting to become effective on January 1, 2029.Source filing
Keytruda (pembrolizumab) — Regulatory decision
Jan 1
As a result of the passage of H.R.1 - One Big Beautiful Bill Act (OBBBA), the Company believes that Keytruda will not be eligible to be selected in 2026 for government price setting under the IRA, which would become effective on January 1, 2028.Source filing
Keytruda (pembrolizumab) — Regulatory decision
Jan 1
Instead, Keytruda will now be eligible to be selected in 2027 for government price setting to become effective on January 1, 2029.Source filing
Keytruda (pembrolizumab) — Conference presentation
Oct 26
The Company will hold an Oncology Investor Event to coincide with the European Society for Medical Oncology Congress 2026 on Monday, Oct. 26, 2026, at 6 p.m. CET / 1 p.m. EDT, during which senior management will provide an update on the Company's oncology strategy and program.Source filing