Drug Approval | April 22, 2026
US FDA okays Merck's new once-daily HIV pill
The newly approved pill combines 100 mg of doravirine with 0.25 mg of islatravir
The newly approved pill combines 100 mg of doravirine with 0.25 mg of islatravir
The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck
The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis
The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks
These findings follow positive Phase 3 results presented earlier this year
Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo
Merck will share two oral presentations on ASCVD treatment patterns and patient burden
Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
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