Is Skyhawk’s SKY-0515 the first disease-modifying breakthrough in Huntington’s disease?
Skyhawk’s SKY-0515 shows functional gains in Huntington’s disease. Find out how RNA modulation could alter the treatment landscape.
Pharma & Biotech
Pharma & Biotech
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.
Pharma & Biotech
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.
Pharma & Biotech
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.
Pharma & Biotech
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.
Medical Devices & Diagnostics
Abanza gains 510(k) for QuadLock ACL system: But is this a clinical leap or an engineering refinement?
Abanza Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for QuadLock, its novel knotless fixation system for anterior cruciate ligament (ACL) reconstruction. The system, which features a bidirectional tension-adjustable design, reportedly offers over a 500% reduction in cyclic displacement compared to conventional fixation methods such as cortical buttons and interference screws, targeting
Pharma & Biotech
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.
Features & Analysis
How Arcutis Biotherapeutics’ control of ZORYVE promotion could influence real-world dermatology and pediatric use
Arcutis Biotherapeutics takes full control of ZORYVE promotion. See how this shift could affect real-world dermatology and pediatric prescribing.
Pharma & Biotech
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.
Features & Analysis
Why Indivior’s Delaware redomiciliation matters more than a corporate address change
Find out how Indivior’s move to the United States reshapes governance, regulation, and investor perception in addiction treatment biotech.