FDA Approves Vepdegestrant for ESR1-Mutant Advanced Breast Cancer
Vepdegestrant approved by FDA for ESR1-mutant advanced breast cancer, reducing progression risk by 43% versus fulvestrant in the VERITAC-2...
FDA Approves Tradipitant, First New Motion Sickness Drug in 40 Years
FDA approves tradipitant, the first new motion sickness drug in 40 years, with clinical trials conducted under actual sea-travel...
Alterity Phase 2 MSA Study Hits Primary Endpoint, Advances FDA Regulatory Path
Alterity's Phase 2 MSA Study hits primary endpoint with 41% relative treatment effect, advancing toward FDA End-of-Phase 2 meeting.
Cocrystal’s CDI-988 norovirus trial enrolls first cohort for human challenge study
CDI-988 norovirus antiviral enters human challenge study with 40 healthy adults enrolled. First proof-of-concept data could address disease with...
Kymera’s KT-621 Advances in Phase 2b Atopic Dermatitis and Asthma Trials
Kymera's KT-621 Phase 2b trials in atopic dermatitis and asthma enrollment complete, with data readouts expected mid-to-late 2027.
Rezolute’s Ersodetug Misses Primary Endpoint in Congenital Hyperinsulinism Trial
Rezolute's ersodetug misses primary endpoint in congenital hyperinsulinism trial, though secondary CGM data shows directional efficacy signals.
FDA Approves Vepdegestrant for ESR1-Mutant Advanced Breast Cancer
FDA Approves Vepdegestrant for ESR1-mutant advanced breast cancer, the first PROTAC therapy. VERITAC-2 showed 5.0-month median progression-free survival versus...
The Protocol That Ate the Timeline: How Scope Creep Becomes a Site Operations Crisis
76% of trials now require protocol amendments—and every one resets IRB clocks, contract cycles, and site activation timelines your...
Semaglutide Just Passed Its Hardest Test Yet — And the FDA Has No Roadmap for What Comes Next
A landmark Lancet RCT shows once-weekly semaglutide cut heavy drinking days in 108 AUD-plus-obesity patients. The FDA approval path...
Indivior’s Phase 2 OUD Drug Fails, Triggering R&D Restructuring
Indivior's Phase 2 OUD drug candidate failed, prompting R&D restructuring and raising questions about the company's pipeline beyond its...