Galmed Pharmaceuticals has acquired Colospan and its CG-100 colorectal bypass device, but European adoption, pivotal United States evidence and financing will determine whether the micro-cap company can create a sustainable medtech business.
Find out how Praxis’ FDA Breakthrough Therapy Designation for elsunersen could reshape SCN2A-DEE epilepsy treatment and ASO development.
Find out how Taysha’s TSHA-102 Rett syndrome update could shape gene therapy development, BLA planning and future disease-modifying care.
Find out how Regeneron’s cemdisiran review could reshape generalized myasthenia gravis care with potential quarterly subcutaneous dosing.
IceCure Medical’s FDA-authorised breast cancer cryoablation platform is gaining United States installations, but narrow eligibility, postmarket evidence requirements and heavy dilution complicate the small-cap investment case.
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.
HyBryte’s setback leaves Soligenix with cash, orphan assets, and a harder question. Can SGX945 reset the rare disease story?
VT ablation remains difficult. Adagio Medical’s pivotal vCLAS data now shifts the question from feasibility to FDA and clinical adoption.
Savara’s molgramostim FDA review was extended to November 22, 2026. Read what this means for autoimmune PAP, launch timing, and regulatory risk.
Parnell’s Noble Pharma acquisition expands U.S. veterinary drug manufacturing capacity. Read what it could change for supply, scale, and market strategy.