Tinlarebant moves closer to FDA review after Belite Bio finishes DRAGON II trial enrollment
Find out how Belite Bio’s DRAGON II milestone moves tinlarebant closer to FDA review as a potential first therapy for Stargardt disease.
Cognition Therapeutics advances regulatory strategy for zervimesine in an underserved neurodegenerative disease
Cognition Therapeutics aligns with FDA on zervimesine Phase 2b plans. Discover what this means for dementia with Lewy bodies drug development.
What Cloudbreak Pharma’s Phase 2 FDA meeting reveals about late-stage risk in ophthalmic drug development
Find out how Cloudbreak Pharma’s Phase 2 FDA meeting reshapes late-stage risk for CBT-004 and what it signals for ophthalmic drug development.
Imviva Biotech secures FDA orphan designation as CD7 CAR-T development faces execution challenges
FDA grants orphan drug designation to Imviva Biotech’s CTD402. Find out what this means for allogeneic CAR-T development in T-cell leukemia.
Can Genentech’s CT-388 challenge obesity drug giants with 22.5% weight loss and β-arrestin bias?
Genentech’s CT-388 hit 22.5% weight loss in Phase II. Find out what this means for obesity drugs, clinical durability, and market strategy in 2026.
Scancell’s late-stage push for iSCIB1+ reframes the risk calculus in advanced melanoma trials
FDA clears Scancell’s iSCIB1+ for Phase 3 testing in advanced melanoma. Discover what this means for immunotherapy risk, trial design, and competition.
What Mirum’s Bluejay acquisition reveals about its long-term liver disease strategy
Mirum adds brelovitug in HDV through Bluejay deal. See how this could redefine rare liver disease leadership ahead of AZURE Phase 3 results in 2026.
Fortitude Biomedicines enters the degradation race with catalytic ADC platform GLUE-DACTM
Fortitude Biomedicines launches with $13M to develop glue-payload ADCs for autoimmune and cancer treatment. Find out what makes this platform different.
Can Sarepta’s ELEVIDYS redefine Duchenne therapy? Inside the 3-year EMBARK data
Sarepta’s gene therapy ELEVIDYS shows 3-year durability in Duchenne muscular dystrophy. Find out what it means for patients, payers, and global rollout.
Nocion Therapeutics reveals new pain data: Is a platform pivot underway?
Find out how Nocion’s nocions™ could change pain treatment by silencing activated neurons without opioids. New preclinical data inside.