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FDA Approval

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

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

The readout points to a one-time gene-editing treatment that could replace chronic drugs for hereditary angioedema.

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

FDA Grants Priority Review to Leqembi Autoinjector for Weekly At-Home Starting Dose

ImmunityBio Sets 30-Day FDA Submission After Positive Meeting on Anktiva Expansion

Novo Nordisk Expands Aspect Partnership, Transfers Diabetes Cell Tech as Aspect Takes Lead

UK Trial Finds FDA-Cleared ADHD Nerve Stimulation Ineffective in Children and Teens