Why clinical biomarkers face a slow climb before regulators accept them as surrogate endpoints
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.
What Soligenix’s Q1 update reveals about biotech risk after a failed confirmatory trial
HyBryte’s setback leaves Soligenix with cash, orphan assets, and a harder question. Can SGX945 reset the rare disease story?
Adagio Medical reports pivotal FULCRUM-VT results as FDA pathway sharpens for vCLAS ablation system
VT ablation remains difficult. Adagio Medical’s pivotal vCLAS data now shifts the question from feasibility to FDA and clinical adoption.
Molgramostim review pushed to November: what Savara’s FDA delay means for autoimmune PAP
Savara’s molgramostim FDA review was extended to November 22, 2026. Read what this means for autoimmune PAP, launch timing, and regulatory risk.
Parnell expands U.S. manufacturing footprint with Noble Pharma acquisition amid supply continuity pressures
Parnell’s Noble Pharma acquisition expands U.S. veterinary drug manufacturing capacity. Read what it could change for supply, scale, and market strategy.
Can Allevion Medical’s Vantage change spinal stenosis workflows by combining disposable access, illumination, and bone resection tools?
Allevion Medical’s Vantage won FDA 510(k) clearance for lumbar decompression. Read what this may change for spinal stenosis workflow, adoption, and risk.
Novo Nordisk’s Awiqli approval could change how basal insulin is used in type 2 diabetes
Novo Nordisk’s Awiqli wins FDA approval as the first once-weekly basal insulin. Read what this could change for type 2 diabetes care.