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FDA Approval

Drug Approval Process Medical Devices Biologics License Application Drug Applications Drug Review Process Drug Development New Drug Application Priority Review Accelerated Approval Drug Safety

FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease

The decision could speed a regulatory ruling that would introduce the first at‑home, subcutaneous treatment option for moderate to severe TED.

FDA Approves Lumvoa for Thyroid Eye Disease

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

FDA Accepts Roche’s Tecentriq for Priority Review in dMMR Stage III Colon Cancer

New Oral Drug Nearly Doubles Survival for Treated Metastatic Pancreatic Cancer

FDA Approves Xocova as First Oral Post-Exposure COVID-19 Prophylaxis

Lorundrostat Produces Blood-Pressure and Albuminuria Drops in Company Post Hoc Phase 3 Analysis

FDA Accepts ImmunityBio Filing to Expand ANKTIVA Use in Bladder Cancer

Milestone Posts Q1 Loss as CARDAMYST Launch Shows Early Uptake and AFib-RVR Phase 3 Begins

Moderna’s mRNA Flu Shot Tops Standard Vaccine in Large Phase 3 Trial

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

FDA Approves Auvelity as First Non‑Antipsychotic for Alzheimer’s Agitation

Pfizer’s Elrexfio Posts Phase 3 PFS Win Over Standard Multiple Myeloma Regimen

Intellia’s Gene-Editing Drug Cuts HAE Attacks 87% in Phase 3 as FDA Filing Begins

Novo Nordisk’s Oral Semaglutide Lowers HbA1c in Teens in Pivotal Trial

KRAS Pill Doubles Survival in Trial as Pancreatic Cancer Vaccine Advances

FDA Expands Tzield Use to Delay Type 1 Diabetes in Children Ages 1 to 7

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

Lilly’s Oral Foundayo Matches Insulin on Heart Safety in Major Diabetes Trial

FDA Approves Filspari to Reduce Proteinuria in FSGS Patients Without Nephrotic Syndrome