Health ❯ Healthcare ❯ Regulatory Affairs

FDA Approvals

Drug Approval Process Medical Devices Drug Safety Novo Nordisk Drug Development New Drug Applications Drug Indications Drug Approvals Biologics License Application Biologics License Application (BLA) Accelerated Approval FDA Drug Designations Zopapogene Imadenovec-Drba COVID-19 Vaccine Approvals Breakthrough Devices Biologics License Applications Alzheimer's Disease Drugs Orphan Drug Designation Drug Efficacy Accelerated Approval Pathway Liso-cel Approval Label Expansions Cancer Drugs New Therapies Belzutifan Cemiplimab Approval Glaukos Corp Omidubicel-onlv Drug Applications Onasemnogene Abeparvovec Gene Therapies Fast Track Designation Drug Formulations Gene Therapy Breakthrough Therapy Designation Drug Labeling Medical Innovations Medical Algorithms Vaccine Approvals New Drug Approvals New Drug Treatments Safety Advisories Miplyffa Drug Safety and Efficacy Breakthrough Device Designation Brensocatib Approval

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression

The readout lands under heightened FDA scrutiny following two liver‑failure deaths in non‑ambulatory patients.

FDA Clears Medtronic’s MiniMed Go App Linking InPen With Abbott’s Instinct CGM

AstraZeneca’s LATIFY Phase 3 Finds No Survival Benefit for Ceralasertib Plus Imfinzi in Pre-Treated NSCLC

FDA Approves Rybrevant Faspro, a 5‑Minute Subcutaneous Amivantamab for EGFR‑Mutated Lung Cancer

FDA Clears First New Oral Gonorrhea Antibiotics in Over 30 Years

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

FDA Approves Amgen’s Uplinza for Generalized Myasthenia Gravis

FDA Approves Orladeyo Oral Pellets to Prevent HAE Attacks in Children Ages 2 to Under 12

FDA Approves One-Time Intrathecal Gene Therapy Itvisma for Older SMA Patients

FDA Approves Breyanzi for Marginal Zone Lymphoma After Two or More Therapies

FDA Approves Novartis’ Itvisma for SMA Patients Ages 2 and Up

Bayer Stroke Drug Asundexian Hits Phase III Goals, Shares Jump

FDA Approves Darzalex Faspro as First Therapy for High-Risk Smoldering Multiple Myeloma

Sarepta Shares Plunge After ESSENCE Phase 3 Miss in Duchenne Trial

Orchestra BioMed Starts U.S. Virtue Coronary Balloon Trial as Terumo Reworks Deal With $30M Support

EU Regulators Back Libtayo as Adjuvant Therapy for High-Risk Cutaneous Squamous Cell Carcinoma

Novartis’ Fabhalta Slows Kidney Function Decline in Final Phase 3 IgAN Results

FDA Approves Libtayo as First Immunotherapy for Adjuvant Treatment of High‑Risk CSCC

Datroway Extends Survival Over Chemotherapy in First-Line TNBC Ineligible for Immunotherapy

Amgen Reports Repatha Cuts First-Event Risk in Primary-Prevention Trial