New Indications and Dosage Forms for 2023

January 12, 2023

• Novo Nordisk Announces FDA Approval of Label Update for Rybelsus (semaglutide) Allowing Use as a First-Line Option for Adults with Type 2 Diabetes

January 17, 2023

• FDA Approves Adacel for Immunization During Pregnancy to Help Protect Young Infants Against Pertussis

January 19, 2023

• Seagen Announces FDA Accelerated Approval of Tukysa (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
• Brukinsa (zanubrutinib) Approved in the U.S. for Chronic Lymphocytic Leukemia

January 25, 2023

• U.S. FDA Approves ALK's Odactra (House Dust Mite Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Adolescents

January 27, 2023

• FDA Approves Keytruda (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)

February 2, 2023

• Tezspire Approved for Self-Administration in the U.S. With a New Pre-filled Pen

February 3, 2023

• U.S. FDA Approves Takeda’s Takhzyro (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks in Children 2 Years of Age and Older
• U.S. FDA Approves Trodelvy in Pre-treated HR+/HER2- Metastatic Breast Cancer

February 8, 2023

• Eylea (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with Retinopathy of Prematurity (ROP) by the FDA

February 10, 2023

• FDA Approves Pfizer's Supplemental New Drug Application for Cibinqo (abrocitinib) to Include Adolescents with Moderate-to-Severe Atopic Dermatitis
• US FDA Grants Regular Approval for Jemperli for the Treatment of Patients with Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer

February 17, 2023

• Teva Announces FDA Approval of Austedo XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of Austedo

February 28, 2023

• Kevzara (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica

March 3, 2023

• FDA Broadens Indication for Verzenio (abemaciclib) in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer

March 16, 2023

• FDA Approves Expanded Indication for Telix’s Illuccix to Include Patient Selection for PSMA-Directed Radioligand Therapy

March 19, 2023

• Novartis Tafinlar + Mekinist Approved by FDA for Pediatric Patients with BRAF V600E Low-Grade Glioma

March 21, 2023

• Sandoz Receives US FDA Approval for Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation

March 22, 2023

• FDA Approves First-in-class Evkeeza (evinacumab-dgnb) for Young Children with Ultra-Rare Form of High Cholesterol

March 29, 2023

• FDA Converts to Full Approval Indication for Keytruda (pembrolizumab) for Certain Adult and Pediatric Patients With Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors
• FDA Approves Over-the-Counter Designation for Emergent BioSolutions’ Narcan Nasal Spray, a Historic Milestone for the Opioid Overdose Emergency Treatment

April 3, 2023

• FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Padcev (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

April 11, 2023

• Takeda Receives FDA Approval to Expand the Use of Hyqvia to Treat Primary Immunodeficiency in Children

April 14, 2023

• Horizon Therapeutics plc Announces FDA Approval of an Update to the Indication Language for Tepezza (teprotumumab-trbw) to Specify its Use in Thyroid Eye Disease (TED) Patients Regardless of Disease Activity or Duration

April 17, 2023

• U.S. FDA Approves Qulipta (atogepant) for Adults With Chronic Migraine

April 18, 2023

• CSL Behring Receives FDA Approval for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe

April 26, 2023

• Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 2 Through 5 With Certain Mutations

April 27, 2023

• U.S. FDA Approves Prevnar 20, Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine for Infants and Children

April 28, 2023

• FDA Approves Once-Weekly Sogroya for the Treatment of Children Living with Growth Hormone Deficiency

May 9, 2023

• Farxiga Extended in the US to Reduce Risk of Cardiovascular Death and Hospitalisation for Heart Failure to a Broader Range of Patients

May 10, 2023

• Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application (sNDA) for Rexulti (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease

May 15, 2023

• Caldolor Now FDA Approved for Treatment of Fever & Pain in Infants

May 19, 2023

• U.S. FDA Approves Rinvoq (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease in Adults

May 22, 2023

• FDA Approves Ayvakit (avapritinib) as the First and Only Treatment for Indolent Systemic Mastocytosis
• US FDA Approves the Cyltezo Pen, a New Autoinjector Option, Ahead of July 1 Commercial Launch

June 1, 2023

• FDA Approves Lynparza (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

June 5, 2023

• Injectafer Approved in the U.S. for the Treatment of Iron Deficiency in Adult Patients with Heart Failure

June 6, 2023

• U.S. FDA Approves New Indication for Merck’s Prevymis (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

June 12, 2023

• Ironwood Pharmaceuticals Announces FDA Approval of New Indication for Linzess (linaclotide) for the Treatment of Functional Constipation in Pediatric Patients Ages 6-17 Years-Old

June 13, 2023

• FDA Approves Bylvay for Patients Living with Cholestatic Pruritus Due to Alagille Syndrome

June 20, 2023

• FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
• Pfizer’s Talzenna (talazoparib) in Combination with Xtandi (enzalutamide) Receives U.S. FDA Approval for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

June 21, 2023

• FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
• FDA Approves Jardiance (empagliflozin) for the Treatment of Type 2 Diabetes in Children 10 Years and Older

July 7, 2023

• FDA Grants Traditional Approval for Leqembi (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

July 10, 2023

• FDA Approves Medicines360’s Supplemental New Drug Application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg as Treatment of Heavy Menstrual Bleeding
• US FDA Approves Expanded Indication for Leqvio (inclisiran) to Include Treatment of Adults with High LDL-C and Who Are At Increased Risk of Heart Disease

July 14, 2023

• FDA Approves Veklury (remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis

July 31, 2023

• Jemperli (dostarlimab-gxly) Plus Chemotherapy Approved in the US for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

August 2, 2023

• FDA Approves Lonsurf (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC)

August 3, 2023

• U.S. FDA Approves Merck’s Ervebo (Ebola Zaire Vaccine, Live) for Use in Children 12 Months of Age and Older

August 9, 2023

• FDA Grants Regular Approval for Gavreto (pralsetinib) for Non-Small Cell Lung Cancer with RET Gene Fusions

August 15, 2023

• FDA Approves First Therapeutic Indication for Revance’s Daxxify (daxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia

August 18, 2023

• Neurocrine Biosciences Announces FDA Approval of Ingrezza (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease

August 21, 2023

• U.S. FDA Approves Abrysvo, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age

August 24, 2023

• FDA Approves Veklury (remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment

August 28, 2023

• U.S. FDA Approves Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions

September 11, 2023

• Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine
• Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine

September 14, 2023

• FDA Approves New and Updated Indications for Temozolomide Under Project Renewal

September 18, 2023

• RedHill Announces FDA sNDA Approval for Simplified Dosage Regimen for Talicia

September 22, 2023

• US FDA Approves Jardiance for the Treatment of Adults with Chronic Kidney Disease

September 27, 2023

• FDA Approves Bosutinib for Pediatric Patients with Chronic Myelogenous Leukemia
• U.S. FDA Approves Subcutaneous Administration of Takeda's Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis

October 2, 2023

• Apellis Announces U.S. FDA Approval of the Empaveli Injector, a Device to Streamline Self-Administration

October 5, 2023

• FDA Grants Interchangeable Designation to Pfizer’s Biosimilar Abrilada

October 6, 2023

• FDA Approves Novartis Cosentyx as First Intravenous (IV) Formulation Interleukin-17A Antagonist for Rheumatic Diseases
• FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11

October 10, 2023

• Biofrontera Inc. Receives FDA Approval for New Formulation of Ameluz

October 11, 2023

• FDA Approves Braftovi (encorafenib) with Mektovi (binimetinib) for Metastatic Non-Small Cell Lung Cancer with a BRAF V600E Mutation

October 13, 2023

• U.S. Food and Drug Administration Approves Opdivo (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma

October 16, 2023

• FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With Resectable NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Single Agent as Adjuvant Treatment After Surgery

October 20, 2023

• FDA Expands Pediatric Indication for Rozlytrek (entrectinib) and Approves New Pellet Formulation
• U.S. Food and Drug Administration Approves BioMarin's Voxzogo (vosoritide) for Children Under 5 Years with Achondroplasia

October 24, 2023

• Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) for the Treatment of IDH1-Mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)

October 26, 2023

• FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

October 31, 2023

• Phathom Pharmaceuticals Announces FDA Approval of Reformulated Vonoprazan Tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults
• FDA Approves Novartis' Cosentyx as the First New Biologic Treatment Option for Hidradenitis Suppurativa Patients in Nearly a Decade

November 1, 2023

• FDA Approves Merck’s Keytruda (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

November 10, 2023

• Pacira Announces FDA Approval of Expanded Exparel Label to Include Two Additional Nerve Block Indications

November 16, 2023

• Pfizer and Astellas' Xtandi Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
• FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

December 1, 2023

• Jaypirca (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor

December 4, 2023

• U.S. Food And Drug Administration Grants Two New Label Changes to Tirosint-SOL (levothyroxine sodium) Oral Solution

December 7, 2023

• FDA Grants Expanded Approval to Wilate as the First VWF Concentrate for Prophylaxis in All Types of VWD

December 8, 2023

• FDA Approves Expanded Use of Cresemba (isavuconazonium sulfate) in Children with Invasive Aspergillosis and Invasive Mucormycosis

December 12, 2023

• ADMA Biologics Announces FDA Approval for Bivigam in the Pediatric Patient Setting for Those 2 Years of Age and Older

December 13, 2023

• Theratechnologies Announces FDA Approval of Trogarzo 90-Second Intravenous (IV) Push Loading Dose
• U.S. FDA Updates LDL-C Lowering Indication for Esperion’s Nexletol (bempedoic acid) Tablet and Nexlizet (bempedoic acid and ezetimibe) Tablet

December 14, 2023

• FDA Approves Merck’s Welireg (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI

December 15, 2023

• Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer
• LEO Pharma Inc. Announces U.S. FDA Approval of Adbry (tralokinumab-ldrm) for the Treatment of Moderate-to-Severe Atopic Dermatitis in Pediatric Patients Aged 12-17 Years
• FDA Approves Arcutis’ Zoryve (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

December 20, 2023

• Calliditas Therapeutics Announces Full FDA Approval of Tarpeyo, the Only FDA-Approved Treatment for IgA Nephropathy to Significantly Reduce the Loss of Kidney Function

December 21, 2023

• U.S. FDA Approves Label Update for Kite’s Yescarta CAR T-Cell Therapy to Include Overall Survival Data

December 22, 2023

• FDA Approves Label Update for Brukinsa (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)

December 26, 2023

• Coherus Announces FDA Approval of Udenyca Onbody™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv