New Indications and Dosage Forms for 2024
See also: New Drug Approvals for 2024
January 12, 2024
January 16, 2024
- U.S. FDA Approves Takeda’s Hyqvia as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Dupixent (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement
- Vertex Announces US FDA Approval of Casgevy (exagamglogene autotemcel) for the Treatment of Transfusion-Dependent Beta Thalassemia
January 19, 2024
January 23, 2024
January 25, 2024
January 29, 2024
January 30, 2024
February 13, 2024
February 15, 2024
February 16, 2024
February 19, 2024
February 20, 2024
February 26, 2024
- Johnson & Johnson Announces Expansion of Imbruvica (ibrutinib) Label in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications
- U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy to Treat People with HIV with Suppressed Viral Loads, Pre-Existing Resistance
March 1, 2024
March 4, 2024
March 6, 2024
March 7, 2024
- U.S. Food and Drug Administration Approves Opdivo (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma
- BeiGene Announces FDA Accelerated Approval of Brukinsa for the Treatment of Relapsed or Refractory Follicular Lymphoma
March 8, 2024
March 11, 2024
March 13, 2024
March 14, 2024
March 15, 2024
March 19, 2024
- FDA Approves Expanded Generalized Pustular Psoriasis Indications for Spevigo
- FDA Approves Edurant PED (rilpivirine) for Certain Pediatric Patients Living with HIV-1
- Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for Iclusig (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL
March 22, 2024
- U.S. FDA Approves Broad New Labels for Nexletol and Nexlizet to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use
- U.S. Food and Drug Administration (FDA) Grants Full Approval for Elahere (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients
March 25, 2024
March 26, 2024
March 28, 2024
April 2, 2024
April 5, 2024
- U.S. FDA Approves Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
- FDA Approves Carvykti for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy
April 6, 2024
April 8, 2024
April 11, 2024
- Xcopri (cenobamate) Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tube
- Fasenra Approved for Treatment of Children Aged 6 to 11 with Severe Asthma
April 18, 2024
- FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer
- U.S. FDA Approves Subcutaneous Administration of Takeda’s Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
April 23, 2024
April 26, 2024
- FDA Approves Biktarvy Label Update With Data for Pregnant Adults With HIV
- Bausch + Lomb Receives FDA Approval of Lumify Preservative Free Redness Reliever Eye Drops