New Indications and Dosage Forms for 2025

January 15, 2025

• Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo (axatilimab-csfr) 9 mg and 22 mg Vial Sizes
• FDA Approves Lilly's Omvoh (mirikizumab-mrkz) for Crohn's Disease, Expanding Its Use to the Second Major Type of Inflammatory Bowel Disease

January 17, 2025

• FDA Approves Lumakras (sotorasib) in Combination with Vectibix (panitumumab) for Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer
• Calquence Plus Chemoimmunotherapy Approved in the U.S. for Patients with Previously Untreated Mantle Cell Lymphoma

January 21, 2025

• Spravato (esketamine) Approved in the U.S. as the First and Only Monotherapy for Adults with Treatment-Resistant Depression

January 27, 2025

• Enhertu Approved as First HER2-Directed Therapy for Patients with HER2-Low or HER2-Ultralow Metastatic Breast Cancer
• FDA Approves Leqembi (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

January 28, 2025

• FDA Approves Ozempic (semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults with Type 2 Diabetes and Chronic Kidney Disease

February 4, 2025

• FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Treatment of Diabetic Macular Edema

February 12, 2025

• FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)
• U.S. FDA Approves Pfizer’s Adcetris Combination Regimen for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
• U.S. FDA Approves Expanded Label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for Geographic Atrophy

February 24, 2025

• Indivior Announces FDA Approval of Label Changes for Sublocade (buprenorphine extended-release) Injection

February 28, 2025

• FDA Approves Odactra for the Treatment of House Dust Mite Allergy in Young Children

March 3, 2025

• FDA Approves TNKase (tenecteplase) for the Treatment of Acute Ischemic Stroke in Adults

March 4, 2025

• Tevimbra Approved in U.S. for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy

March 5, 2025

• ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions in Pediatric Patients

March 7, 2025

• scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the Furoscix Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease

March 10, 2025

• FDA Approves Expanded Use of Soliris (eculizumab) for Pediatric Myasthenia Gravis, Bringing New Treatment Options for Children

March 14, 2025

• ANI Pharmaceuticals Announces FDA Approval for Expansion of Iluvien Label

March 19, 2025

• FDA Approves Pembrolizumab for HER2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1 (CPS ≥1)

March 20, 2025

• Alnylam Announces FDA Approval of Amvuttra (vutrisiran), the First RNAi Therapeutic to Reduce Cardiovascular Death, Hospitalizations and Urgent Heart Failure Visits in Adults with ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)
• FDA Approves Tremfya (guselkumab) for Adult Patients with Moderately to Severely Active Crohn’s Disease

March 21, 2025

• Novartis Receives Third FDA Approval for Oral Fabhalta (iptacopan), the First and Only Treatment Approved in C3 Glomerulopathy

March 25, 2025

• Theratechnologies Receives FDA Approval for Egrifta WR (tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy

March 26, 2025

• Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors

March 28, 2025

• FDA Approves Novartis Radioligand Therapy Pluvicto for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
• FDA Approves Imfinzi (durvalumab) for Muscle Invasive Bladder Cancer

March 31, 2025

• Bavarian Nordic Receives U.S. FDA Approval of Jynneos Freeze-Dried Smallpox and Mpox Vaccine

April 3, 2025

• Uplizna (inebilizumab-cdon) is Now the First and Only FDA-Approved Treatment for IgG4-Related Disease

April 8, 2025

• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as a Treatment for Patients with Previously Untreated Microsatellite Instability-High or Mismatch Repair Deficient Unresectable or Metastatic Colorectal Cancer

April 9, 2025

• FDA Approves an Updated Label for Tryvio (aprocitentan) Removing the REMS Requirement

April 10, 2025

• U.S. FDA Grants Full Approval of Vitrakvi (larotrectinib) for Adult and Pediatric Patients with NTRK Gene Fusion-Positive Solid Tumors
• Argenx Announces FDA Approval of Vyvgart Hytrulo Prefilled Syringe for Self-Injection

April 11, 2025

• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

April 14, 2025

• FDA Grants Interchangeable Designation to Yuflyma (adalimumab-aaty), Celltrion's Biosimilar to Humira (adalimumab)
• Mirum’s Livmarli Now FDA Approved in Tablet Formulation

April 16, 2025

• Neurelis Announces FDA Approval for Immediate Use Seizure Medication Valtoco (diazepam nasal spray) in Ages 2 to 5 Years
• FDA Grants Isturisa (osilodrostat) Expanded Indication for the Treatment of Endogenous Hypercortisolemia in Patients with Cushing’s Syndrome

April 17, 2025

• U.S. Food and Drug Administration Updates Camzyos (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications

April 18, 2025

• Dupixent (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)