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 25, 2024

• FDA Approves Otezla (Apremilast) for the Treatment of Pediatric Patients 6 years of Age and Older With Moderate to Severe Plaque Psoriasis

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 29, 2024

• FDA Grants Accelerated Approval to Retevmo (selpercatinib) for Pediatric Patients Two Years and Older with RET-Altered Metastatic Thyroid Cancer or Solid Tumors
• Teva Announces Austedo XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option for Clinically Therapeutic Doses

May 30, 2024

• Catalyst Pharmaceuticals Receives U.S. FDA Approval for Increased Maximum Daily Dose for Firdapse
• 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

June 7, 2024

• New Indication for Motpoly XR (Lacosamide Extended-Release) Capsules for Primary Generalized Tonic-Clonic Seizures (Adjunctive Treatment)

June 10, 2024

• FDA Approves Expanded Age Indication for GSK’s Arexvy, the First Respiratory Syncytial Virus (RSV) Vaccine for Adults Aged 50-59 at Increased Risk
• FDA Approves Almirall’s Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on Expanded Area of Face or Scalp

June 11, 2024

• FDA Approves Kevzara (sarilumab) for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)

June 12, 2024

• FDA Approves Xigduo XR (dapagliflozin/metformin) for Glycemic Control in Children Aged 10 Years and Older with Type-2 Diabetes
• FDA Grants Traditional Approval for Retevmo (selpercatinib) for RET Fusion-Positive Thyroid Cancer
• FDA Approves Farxiga (dapagliflozin) for Glycemic Control in Children Aged 10 Years and Older with Type-2 Diabetes

June 13, 2024

• FDA Approves Adbry (tralokinumab-ldrm) Autoinjector for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis (AD)
• FDA Approves Augtyro (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors

June 14, 2024

• FDA Approves Blincyto (blinatumomab) in CD19-Positive Philadelphia Chromosome-Negative B-ALL in the Consolidation Phase
• FDA Approves Imfinzi (durvalumab) for Mismatch Repair Deficient Primary Advanced or Recurrent Endometrial Cancer

June 17, 2024

• FDA Approves Merck’s Keytruda (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma

June 18, 2024

• FDA Approves Skyrizi (risankizumab-rzaa) for Ulcerative Colitis

June 20, 2024

• Sarepta Therapeutics Announces Expanded US FDA Approval of Elevidys to Duchenne Muscular Dystrophy Patients Ages 4 and Above

June 21, 2024

• Argenx Announces FDA Approval of Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy
• Bristol Myers Squibb Announces U.S. FDA Accelerated Approval of Krazati (adagrasib) in Combination with Cetuximab for Adult Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)
• FDA Converts Tuberculosis Treatment Sirturo to Traditional Approval

June 24, 2024

• Harmony Biosciences Receives U.S. Food And Drug Administration Approval for Wakix (pitolisant) In Pediatric Patients With Narcolepsy

June 27, 2024

• Epkinly (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

July 4, 2024

• FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss

July 9, 2024

• FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age

July 18, 2024

• Phathom Pharmaceuticals Announces FDA Approval of Voquezna (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in Adults

July 19, 2024

• FDA Approves Zituvimet XR (sitagliptin and metformin hydrochloride) Extended-Release Tablets for Adults with Type 2 Diabetes

July 23, 2024

• Merz Aesthetics Announces FDA Approval of Xeomin (incobotulinumtoxinA) as the First and Only U.S. Neurotoxin for the Simultaneous Treatment of Upper Facial Lines

July 24, 2024

• U.S. Food and Drug Administration Approves BioMarin's Brineura (cerliponase alfa) for Children Under 3 Years with CLN2 Disease

July 25, 2024

• Mirum’s Livmarli Now Approved for PFIC in Patients 12 Months and Older

July 26, 2024

• FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] for Use in Individuals Ages 1 through 3 Years With a Confirmed Diagnosis of Peanut Allergy

July 29, 2024

• Grifols Receives Approval for Expanded Xembify (immune globulin subcutaneous human-klhw) Label in U.S.

July 30, 2024

• Darzalex Faspro (daratumumab and hyaluronidase-fihj)-Based Quadruplet Regimen Approved in the U.S. for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant-Eligible

August 1, 2024

• FDA Expands Jemperli (dostarlimab-gxly) Plus Chemotherapy Approval to All Adult Patients with Primary Advanced or Recurrent Endometrial Cancer

August 8, 2024

• Novartis Receives FDA Accelerated Approval for Fabhalta (iptacopan) for the Reduction of Proteinuria in Primary IgA Nephropathy (IgAN)

August 12, 2024

• scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the Furoscix Indication in Heart Failure

August 15, 2024

• Vericel Announces FDA Approval of NexoBrid for the Treatment of Pediatric Patients with Severe Thermal Burns

August 16, 2024

• Imfinzi Approved in the US for the Treatment of Resectable Non-Small Cell Lung Cancer Before and After Surgery

August 22, 2024

• Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine
• Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2

August 29, 2024

• Emergent BioSolutions’ ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication

September 3, 2024

• Azurity Pharmaceuticals, Inc. Announces FDA Approval of Nymalize (nimodipine) Oral Solution 30 mg/5 mL Prefilled ENFit® Syringe

September 5, 2024

• Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy

September 13, 2024

• Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative Colitis
• Dupixent Approved in the US as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

September 17, 2024

• FDA Approves Kisqali to Reduce Risk of Recurrence in People with HR+/HER2- Early Breast Cancer

September 18, 2024

• Fasenra Approved in the US for Eosinophilic Granulomatosis with Polyangiitis
• FDA Approves Merck’s Keytruda (pembrolizumab) Plus Pemetrexed and Platinum Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma (MPM)

September 19, 2024

• Rybrevant (amivantamab-vmjw) Plus Standard of Care Approved in the U.S. as First and Only Targeted Regimen to Cut Risk of Disease Progression by More Than Half in Second-Line EGFR-Mutated Advanced Lung Cancer

September 20, 2024

• FluMist Approved for Self-Administration in the US
• Sarclisa Approved in the US as the First Anti-CD38 Therapy in Combination with Standard-of-Care Treatment for Adult Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

September 23, 2024

• UCB Announces U.S. FDA Approvals for Bimzelx (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis

September 26, 2024

• Tagrisso Approved in the US for Patients with Unresectable, Stage III EGFR-Mutated Lung Cancer

September 27, 2024

• FDA Grants Traditional Approval to Retevmo (selpercatinib) for Medullary Thyroid Cancer with a RET Mutation
• Dupixent Approved in the US as the First-Ever Biologic Medicine for Patients with COPD

October 3, 2024

• U.S. Food and Drug Administration Approves Perioperative Treatment of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable Non-Small Cell Lung Cancer (NSCLC)

October 7, 2024

• FDA Approves Use of Up To Three Tubes of Biofrontera Inc.'s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment

October 14, 2024

• UCB Receives U.S. FDA Approval for 320 mg Single-Injection Device Presentations of Bimzelx (bimekizumab-bkzx)

October 17, 2024

• Avadel Pharmaceuticals Announces FDA Approval of Lumryz (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with Narcolepsy

October 18, 2024

• Botox Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands)

October 22, 2024

• Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of Selarsdi (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara (ustekinumab)
• U.S. FDA Approves Pfizer’s RSV Vaccine Abrysvo for Adults Aged 18 to 59 at Increased Risk for Disease

October 29, 2024

• Protega Pharmaceuticals Receives FDA Approval for RoxyBond (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Pain
• Novartis Scemblix Granted FDA Accelerated Approval in Newly Diagnosed CML
• Shorla Oncology Announces U.S. FDA Expanded Approval of Jylamvo (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications

November 20, 2024

• UCB Receives U.S. FDA Approval for Bimzelx (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate to Severe Hidradenitis Suppurativa

December 5, 2024

• Imfinzi Approved in the US as First and Only Immunotherapy Regimen for Patients with Limited-Stage Small Cell Lung Cancer

December 9, 2024

• FDA Approves Simplified Dosing Regimen for Acetadote (N-acetylcysteine for injection)

December 15, 2024

• Galderma Receives U.S. FDA Approval for Nemluvio (nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis

December 16, 2024

• FDA Approves Vtama (tapinarof) Cream for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

December 20, 2024

• Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Patients as Young as 2 Years Old
• Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del Trikafta-Responsive Variants
• FDA Approves Zepbound (tirzepatide) as the First and Only Prescription Medicine for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity
• U.S. FDA Approves Pfizer’s Braftovi Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer

December 23, 2024

• Sumitomo Pharma America Announces U.S. FDA Approval of Gemtesa (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

December 27, 2024

• Tevimbra Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with Chemotherapy