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FDA Approval

Drug Approval Process Medical Devices Drug Development Biologics License Application Drug Safety Diagnostic Tests Priority Review Drug Applications Clinical Guidelines Clinical Trials

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

The decision rests on biomarker gains with a confirmatory trial still required.

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

Tecvayli Cuts Progression Risk 71% and Deaths 40% in Phase 3 Myeloma Trial

NEJM Publishes Phase 3 Data Showing Ajovy Reduces Pediatric Migraine Days

FDA Grants Priority Review to Vera's Atacicept for IgA Nephropathy

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

Takeda’s AI-Assisted Psoriasis Pill Succeeds in Phase 3, Outperforms Otezla

Lilly’s Daily Obesity Pill Sustains Weight Loss After Switch From Wegovy or Zepbound

FDA Clears Enhertu-Perjeta Combo for First-Line HER2-Positive Metastatic Breast Cancer

Nektar’s Alopecia Drug Misses Phase 2b Goal as Company Cites Ineligible Patients, Plans Phase 3

FDA Grants Fast Track to Palvella’s QTORIN Rapamycin for Angiokeratomas

Kyverna CAR-T Delivers Positive Phase 2 Topline in Stiff Person Syndrome as Shares Jump

FDA Approves Two First-in-Class Oral Treatments for Gonorrhea