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FDA Approval

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

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

The findings set up an FDA decision due by August 5.

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

IDEAYA Combo Doubles Progression-Free Survival in Uveal Melanoma Trial

FDA Approves Higher‑Dose Spinraza Regimen for Spinal Muscular Atrophy

NEJM Publication Confirms Phase 3 Win for Brepocitinib in Dermatomyositis

FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

PrimeC Shows Safety and Potential Benefit in ALS Phase 2b as FDA Authorizes Phase 3

Grail Shares Plunge About 50% After NHS-Galleri Trial Misses Primary Endpoint

Psilocybin Therapy Clears Second Phase 3 Test as Compass Pathways Preps FDA Bid

CagriSema Beats Semaglutide on HbA1c and Weight at 68 Weeks in Type 2 Diabetes Trial