Clinical Research

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FDA Accepts uniQure’s Huntington’s Gene Therapy for Priority Review, Sets May 1, 2027 Decision Date

This marks an FDA reversal and opens an accelerated‑approval review that requires a 200‑patient randomized trial to confirm any clinical benefit.

MIT Shows Implanted Magnets Can Track Muscle Motion to Improve Prosthetic Control

Surgeon Remotely Removes Prostate 35 Miles Away in U.S. Telesurgery Study

FDA Clears Sequel’s twiist Pump for Adults With Insulin‑Treated Type 2 Diabetes

FDA Approves Enspryng as First At-Home Shot for Thyroid Eye Disease

FDA Expands Anktiva Label to Treat BCG‑Unresponsive High‑Grade Papillary‑Only Bladder Cancer

Study Finds Auto‑Antibodies to DNA‑Repair Proteins Enriched in Children Who Develop Cancer

FDA Approves Weltruza, First Monthly Subcutaneous Olanzapine for Schizophrenia

FDA Approves Tecentriq With Chemotherapy for Stage III dMMR Colon Cancer

FDA Approves Teva’s Once-Monthly Olanzapine Injection, WELTRUZA

Isomorphic Labs Reportedly Seeks $40–$50 Billion Valuation in Early Funding Talks

FDA Expands Remibrutinib Label to Treat Symptomatic Dermographism

U.S. Spending on GLP‑1 Drugs Rises to $64.9 Billion as Patient Costs Bite

FDA to Convene Advisory Panel to Review Grail’s Galleri Cancer Screening Test

Psilocybin Therapy Puts Most Veterans With Treatment‑Resistant PTSD Into Remission

FDA Approves Xocova as First U.S. Post-Exposure COVID-19 Antiviral

Semaglutide Patents Lapse in India and China as Safety Scrutiny Rises

FDA Approves Teclistamab–Daratumumab Combination for Relapsed Multiple Myeloma After One Prior Therapy

FDA Grants Priority Review to Otsuka’s ADHD Drug Centanafadine With July 24 Decision Date

AstraZeneca Withdraws Andexxa From U.S. Market After FDA Says Risks Outweigh Benefits