New Indications and Dosage Forms for 2024

January 12, 2024

• FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

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

• U.S. Food and Drug Administration Grants Full Approval for Balversa to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

January 23, 2024

• Heron Therapeutics Announces FDA Approval of Zynrelef Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures

January 25, 2024

• Dupixent (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)

January 29, 2024

• Takeda’s Gammagard Liquid Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

January 30, 2024

• Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta CAR T-cell Therapy

February 13, 2024

• Ipsen’s Onivyde Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Adenocarcinoma, Approved by FDA

February 15, 2024

• FDA Grants Traditional Approval to Tepmetko (tepotinib) for Metastatic Non-Small Cell Lung Cancer

February 16, 2024

• FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

February 19, 2024

• Tagrisso With the Addition of Chemotherapy Approved in the US for Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer

February 20, 2024

• Tecvayli (teclistamab-cqyv) Biweekly Dosing Approved by the U.S. FDA for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

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

• Rybrevant (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

March 4, 2024

• Lantheus Announces the FDA Approval of Definity (Perflutren Lipid Microsphere) for Pediatric Patients

March 6, 2024

• FDA Approves Besponsa (inotuzumab ozogamicin) for Pediatric Patients with Acute Lymphoblastic Leukemia

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

• Wegovy Approved in the US for Cardiovascular Risk Reduction in People with Overweight or Obesity and Established Cardiovascular Disease

March 11, 2024

• Praluent (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol

March 13, 2024

• Mirum Pharmaceuticals’ Livmarli Receives FDA Approval for Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis

March 14, 2024

• U.S. FDA Approves Bristol Myers Squibb’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

March 15, 2024

• Xhance Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps

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

• Ultomiris Approved in the US for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder (NMOSD)

March 26, 2024

• FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patients

March 28, 2024

• FDA Expands Indication for Gilead's Vemlidy (tenofovir alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six

April 2, 2024

• Vanda Pharmaceuticals' Fanapt (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorder

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

• Enhertu Approved in the US as First Tumor-Agnostic HER2-Directed Therapy for Previously Treated Patients with Metastatic HER2-Positive Solid Tumors

April 8, 2024

• ViiV Healthcare Announces U.S. FDA Approval of Dovato (dolutegravir/lamivudine) for Adolescents Living with HIV

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

• Novartis Radioligand Therapy Lutathera FDA Approved as First Medicine Specifically for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors

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

April 29, 2024

• FDA Grants Full Approval for Tivdak to Treat Recurrent or Metastatic Cervical Cancer

April 30, 2024

• Neurocrine Biosciences Announces U.S. FDA Approval of Ingrezza Sprinkle (valbenazine) Capsules

May 2, 2024

• US FDA Approves High-Concentration, Citrate-Free Formulation of Cyltezo (adalimumab-adbm) injection

May 8, 2024

• Select Strengths of Sandoz Biosimilar Hyrimoz Granted Interchangeability by FDA

May 10, 2024

• FDA Approves Updated Altuviiio Label With Expanded Pediatric Data Confirming Highly Effective Bleed Protection in Children With Hemophilia

May 13, 2024

• Baxter Secures FDA Approval of Clinolipid (Lipid Injectable Emulsion) Neonatal and Pediatric Indication

May 15, 2024

• Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma

May 20, 2024

• FDA Approves Benlysta (belimumab) Autoinjector for Children with Systemic Lupus Erythematosus

May 30, 2024

• U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma