Drugs and Medications Approvals and Updates
- Loargys: FDA Approves the First and Only Injectable Enzyme Therapy, Paired With a Low‑Protein Diet, to Lower High Arginine Levels in Patients Ages 2 Years or Older With Arginase 1 Deficiency
February 24, 2026 — The FDA has approved Loargys (pegzilarginase-nbln), to be used along with a low-protein diet, to manage high levels of the amino acid arginine caused by arginase 1 deficiency (ARG1‑D).
- Calquence Plus Venclexta: FDA Approves First All‑Oral Fixed‑Duration Regimen for Adults With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
February 23, 2026 — The FDA has approved a new combination treatment for adults with certain cancers of the blood and lymphatic system. The targeted regimen combines Calquence (acalabrutinib) tablets with Venclexta (venetoclax) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Bysanti: FDA Approves New Atypical Antipsychotic Pill for Adults with Schizophrenia or Manic/Mixed Episodes in Bipolar I Disorder
February 23, 2026 — The FDA has approved the oral medicine Bysanti (milsaperidone) for treating schizophrenia, as well as for first-line therapy for the acute treatment of manic or mixed episodes that come with bipolar I disorder.
- Rybrevant Faspro: FDA Approves Once-Monthly Dosing in Combination With Lazcluze for EGFR-Mutated Lung Cancer
February 20, 2026 — The FDA has approved a new monthly dosing option for Rybrevant Faspro to be used with lazertinib (Lazcluze) as a first‑line treatment for people with advanced non‑small-cell lung cancer who have certain mutations in the epidermal growth factor receptor (EGFR) gene.
- Adquey: FDA Approves New Nonsteroidal Ointment for Mild to Moderate Eczema
February 19, 2026 — The FDA has approved Adquey (difamilast 1%), a nonsteroidal ointment, for adults and children 2 and older who have mild to moderate atopic dermatitis, also called eczema.
- FDA Approves Rybrevant Faspro: A Time-Saving Under-the-Skin Injection for Use in Combination With Lazcluze for EGFR-Mutated Lung Cancer
February 18, 2026 — The FDA has approved the use of Rybrevant Faspro, combined with another medicine, as a first-line treatment for non-small-cell lung cancer (NSCLC) that has certain mutations in the EGFR (epidermal growth factor receptor) gene.
- Wakix: FDA Expands Approval to Treat Sudden Muscle Weakness in Children With Narcolepsy
February 18, 2026 — Wakix (pitolisant) is a prescription medication used to treat narcolepsy, a long-term neurological sleep disorder that causes excessive daytime sleepiness and, in many cases, cataplexy (sudden muscle weakness triggered by strong emotions). The FDA has approved Wakix to treat cataplexy in children ages 6 and older with narcolepsy.
- Keytruda With Paclitaxel: FDA Approves New Combination Therapy for Certain Cancers Affecting the Ovaries, Fallopian Tubes, or Peritoneum
February 11, 2026 — The FDA has approved Keytruda with paclitaxel as a new combination therapy for certain adults with epithelial cancers that start in the ovaries, fallopian tubes, or lining of the abdomen (peritoneum) and that have not responded to platinum-based chemotherapy.
- Vybrique Gets FDA Nod as a First Oral Film for Treating Erectile Dysfunction
February 9, 2026 — Vybrique (sildenafil) is a new form of treatment for erectile dysfunction (ED) in adult men. It’s the first version of sildenafil available in the U.S. as a single-dose oral film that dissolves on your tongue (without needing water or other liquids) and can be taken 30 minutes to four hours before sexual activity.
- Yuvezzi: First Combination Eye Drop for Age-Related Near Vision Loss
January 30, 2026 — The FDA has approved Yuvezzi as the first eye drop that combines two active ingredients – carbachol and brimonidine tartrate – to improve near vision without surgery.
- FDA Approves Darzalex Faspro as Part of a New First-Line Quadruplet Regimen for Multiple Myeloma
January 29, 2026 — The FDA has approved Darzalex Faspro for use in combination with bortezomib, lenalidomide, and dexamethasone (the D-VRd regimen), for adults with newly diagnosed multiple myeloma who are unable to receive a stem cell transplant.
- Zycubo: FDA Approves First Under-the-Skin Shot for Treating Menkes Disease in Children
January 13, 2026 — The FDA has approved Zycubo (copper histidinate), a new injection under the skin that treats children with Menkes disease, a rare genetic condition that affects copper metabolism.
- FDA Approves Cablivi: New Treatment Option for Rare Blood Clotting Disorder in Children Ages 12 Years and Older
January 6, 2026 — The FDA has approved Cablivi (caplacizumab), to be used along with plasma exchange and immunosuppressive therapy, to treat a rare and serious blood condition called acquired thrombotic thrombocytopenic purpura (aTTP) in children ages 12 years and older.
- Nereus: FDA Approves New Pill to Help With Motion Sickness
January 2, 2026 — Nereus (tradipitant) has become the first new prescription medicine for motion sickness approved by the FDA in more than 40 years.
- FDA Approves Yartemlea, the First and Only Treatment for Transplant-Related Blood Vessel Damage
December 29, 2025 — The FDA has approved Yartemlea (narsoplimab-wuug) to treat a rare and serious condition called transplant-associated thrombotic microangiopathy (TA-TMA) in adults and in children ages 2 and older.
- Aqvesme: FDA Approves First Pill for Treating Anemia in Adults With Alpha- or Beta- Thalassemia
December 24, 2025 — Aqvesme (mitapivat) is a new oral medicine approved by the FDA for treating anemia in adults with alpha- or beta-thalassemia, including those who need and those who don’t require regular blood transfusions.
- Accrufer: FDA Expands Use of Oral Iron Treatment for Kids Ages 10 and Older
December 23, 2025 — The FDA has approved Accrufer (ferric maltol), an oral capsule, to treat iron deficiency in kids ages 10 years and older, providing an option that doesn’t involve getting iron through an injection or intravenous (IV) line.
- Lunsumio Velo: FDA Approves a Convenient Under-the-Skin Shot for Relapsed or Refractory Follicular Lymphoma
December 23, 2025 — The FDA has granted accelerated approval to Lunsumio Velo (mosunetuzumab-axgb) for treating adults with follicular lymphoma that has come back (relapsed) or stopped responding (refractory) after they've had at least two previous treatments.
- FDA Approves Once-Daily Wegovy Pill as the First Oral GLP-1 Medicine for Weight Loss in Adults With Obesity or Overweight
December 23, 2025 — The FDA has approved the oral pill form of Wegovy (semaglutide), to be used along with a low-calorie diet and increased physical activity, to help adults with obesity, or those who are overweight with weight-related medical conditions, lose weight and keep it off.
- Fesilty: FDA Approves New Treatment Option for Rare Bleeding Disorder
December 22, 2025 — The FDA has approved Fesilty (fibrinogen, human-chmt) to treat sudden bleeding episodes in children and adults who have a rare condition called congenital fibrinogen deficiency, or CFD.
- FDA Approves Myqorzo, a New Oral Therapy for Obstructive Hypertrophic Cardiomyopathy
December 22, 2025 — The FDA approves Myqorzo (aficamten) as a new oral medicine for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). It relieves symptoms, improves heart function, and provides stamina for daily activities.
- FDA Expands Jascayd Approval to Adults With Progressive Pulmonary Fibrosis
December 22, 2025 — The FDA has approved Jascayd (nerandomilast) as a treatment for adults with progressive pulmonary fibrosis (PPF) that causes gradual and permanent scarring in the lungs, making it harder to breathe over time.
- FDA Approves Rybrevant Faspro: An Under-the-Skin Injection for Use in Combination With Lazcluze for EGFR-Mutated Lung Cancer
December 18, 2025 — The FDA has approved Rybrevant Faspro in combination with another medicine called lazertinib (Lazcluze) as a first-line treatment for a type of lung cancer called non-small-cell lung cancer (NSCLC) that has certain genetic changes (mutations) in the EGFR (epidermal growth factor receptor) gene.
- Exdensur: FDA Approves New Twice-Yearly Medicine for Severe Asthma
December 18, 2025 — Exdensur (depemokimab) is a new type of ultra long-acting biologic medicine approved by the FDA as an add-on maintenance treatment for severe eosinophilic asthma.
- Enhertu Plus Pertuzumab: New First-Line Option for Advanced HER2-Positive Metastatic Breast Cancer
December 17, 2025 — Enhertu (fam-trastuzumab deruxtecan-nxki) is a type of targeted cancer treatment called an antibody-drug conjugate. The FDA has approved it in combination with another medicine, pertuzumab, as the first-line treatment for adults with HER2-positive breast cancer that has spread (metastatic) or cannot be removed with surgery (unresectable).
- FDA Approves Lerochol: A Monthly Injectable Treatment to Reduce High LDL Cholesterol Levels in Adults
December 17, 2025 — Lerochol (lerodalcibep-liga) is a new medicine approved by the FDA to help lower elevated levels of low-density lipoprotein cholesterol (LDL-C), often called “bad cholesterol,” in adults with hypercholesterolemia (high cholesterol levels), including those with a genetic form called heterozygous familial hypercholesterolemia (HeFH).
- Addyi: FDA Approves New Treatment for Low Sexual Desire in Postmenopausal Women
December 17, 2025 — Addyi (flibanserin) is a nonhormonal prescription pill that is now approved by the FDA to treat low sexual desire in women younger than 65, including those who are postmenopausal.
- FDA Approves Nuzolvence: A First-in-Class, Single-Dose Oral Antibiotic for Drug-Resistant Gonorrhea
December 15, 2025 — Nuzolvence (zoliflodacin) is a new oral antibiotic approved by the FDA to treat uncomplicated gonorrhea of the urinary and genital tract.
- Cardamyst: FDA Approves First Rapid-Acting Self-Use Nasal Spray for Sudden Fast Heartbeats (PSVT)
December 15, 2025 — Cardamyst (etripamil) is a new nasal spray for treating sudden episodes of fast heartbeats, known as paroxysmal supraventricular tachycardia (PSVT).
- FDA Approves Akeega: Once-Daily Therapy Combined With Prednisone for BRCA2-Mutated Metastatic Prostate Cancer
December 15, 2025 — Akeega combines two medicines for treating men with prostate cancer with a BRCA2 mutation that has spread.
- FDA Approves Uplizna: A Twice-Yearly Targeted Therapy for Adults With Generalized Myasthenia Gravis
December 12, 2025 — Uplizna (inebilizumab-cdon) is a prescription medicine recently approved by the FDA to treat adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies.
- FDA Approves Blujepa: First New Oral Antibiotic for Gonorrhea in Decades
December 12, 2025 — Blujepa (gepotidacin) is an oral antibiotic for treating two common infections: uncomplicated urinary tract infections (UTIs) in females and uncomplicated urogenital gonorrhea.
- Waskyra: First Gene Therapy for Wiskott-Aldrich Syndrome
December 10, 2025 — The FDA has approved Waskyra (etuvetidigene autotemcel) as the first gene therapy to treat Wiskott-Aldrich syndrome (WAS), a rare inherited condition that affects the immune system and blood cells.
- Omisirge: A New Cell Therapy for Severe Aplastic Anemia and Blood Cancers
December 8, 2025 — The FDA has approve Omisirge (omidubicel-onlv), a drug made from umbilical cord blood that helps your body make new blood cells after a stem cell transplant, to treat a rare condition called severe aplastic anemia (SAA).
- FDA Approves Breyanzi: First and Only CAR T-Cell Therapy for Relapsed or Refractory Marginal Zone Lymphoma
December 5, 2025 — The FDA has approved Breyanzi (lisocabtagene maraleucel) for adults who have a blood cancer called marginal zone lymphoma (MZL) that has come back (relapsed) or hasn’t responded well to two or more previous therapies (refractory).
- Imfinzi: FDA Approves New Treatment Option for Early, Resectable, and Locally Advanced Gastric and Gastroesophageal Junction Cancers
December 1, 2025 — The FDA has approved a combination of Imfinzi (durvalumab) and standard chemotherapy medicines for treating adults with early-stage or locally advanced stomach (gastric) or gastroesophageal junction (GEJ) cancer that can be removed via surgery (resectable cancer).
- Voyxact: FDA Grants Accelerated Approval to Once-Monthly Injection for Adults With IgA Nephropathy
November 26, 2025 — Voyxact (sibeprenlimab-szsi) is a new medicine approved by the FDA to lower protein levels in urine for adults with a kidney condition called primary immunoglobulin A nephropathy (IgAN) who are at risk of their illness getting worse.
- Itvisma: FDA Approves One-Time Gene Therapy for Spinal Muscular Atrophy in Children 2 or Older, Teens, and Adults
November 25, 2025 — The FDA has approved Itvisma (onasemnogene abeparvovec-brve) as a gene therapy to treat spinal muscular atrophy (SMA) in adults, teens, and children 2 or older who have a mutation in the survival motor neuron 1 (SMN1) gene.
- Hyrnuo: New Oral Treatment for Advanced HER2-Mutant Lung Cancer
November 24, 2025 — Hyrnuo (sevabertinib) is a new oral kinase inhibitor medicine for adults with advanced nonsquamous non-small-cell lung cancer (NSCLC) carrying a specific genetic change and whose cancer has either advanced locally or has spread to other parts of the body.
- Keytruda and Padcev: FDA Approves New Combination Therapy for Aggressive Bladder Cancer
November 24, 2025 — The FDA has approved a combination therapy that uses two anticancer medicines – Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) plus Padcev (enfortumab vedotin) – to treat adults with muscle-invasive bladder cancer (MIBC) who can't use cisplatin, a common chemotherapy drug.
- Eylea HD: New Option for Treating Vision Loss from Macular Edema Caused by Retinal Vein Occlusion
November 24, 2025 — The FDA has approved Eylea HD (aflibercept) to treat macular edema from retinal vein occlusion (RVO).
- Koselugo: FDA Approves Second Oral Treatment for Adults With Neurofibromatosis Type 1
November 21, 2025 — The FDA has approved the oral medication selumetinib (Koselugo) for adults with neurofibromatosis type 1 (NF1) who have tumors called plexiform neurofibromas (PN) that are symptomatic and cannot be surgically removed.
- Imdelltra Receives Full FDA Approval as First-In-Class Immunotherapy for Advanced Small-Cell Lung Cancer
November 21, 2025 — Imdelltra (tarlatamab-dlle) is a first-of-its kind targeted cancer medicine called a bispecific T-cell engager approved for treating adults with extensive-stage small-cell lung cancer (ES-SCLC) that has gotten worse on or after chemotherapy with platinum-based cancer drugs.
- Epkinly: FDA Approves New Bispecific Antibody Option for Relapsed or Refractory Follicular Lymphoma
November 19, 2025 — The FDA has approved Epkinly (epcoritamab-bysp), a medicine that helps your immune system find and destroy certain cancer cells, to be used with two other medicines – rituximab and lenalidomide – to treat adults with a form of blood cancer known as follicular lymphoma.
- FDA Approves Redemplo to Lower Triglycerides in Adults With Familial Chylomicronemia Syndrome
November 19, 2025 — Redemplo (plozasiran) is a type of medicine called a small interfering RNA (siRNA) therapy approved to help lower extremely high triglyceride levels in adults with familial chylomicronemia syndrome (FCS) or ongoing chylomicronemia.
- FDA Approves Ziftomenib: First Once-Daily Oral Therapy for Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
November 13, 2025 — Ziftomenib, sold under the brand name Komzifti, has been approved to treat adults with acute myeloid leukemia (AML) that has come back or hasn’t responded to other treatments and who have a genetic change called an NPM1 mutation.
- Darzalex Faspro: A New Treatment for High-Risk Smoldering Multiple Myeloma
November 7, 2025 — Darzalex Faspro is a medicine used to treat adults with multiple myeloma, a type of blood cancer, and amyloidosis, a rare condition where abnormal proteins build up in organs.
- Caplyta: A New Add-On Option for Adults With Depression
November 6, 2025 — Caplyta (lumateperone), a once-daily oral medicine, has been approved to be used with antidepressants to treat major depressive disorder (MDD) in adults.
- Linzess: First Drug Approved for Children and Adolescents With IBS-C
November 5, 2025 — The FDA has approved Linzess (linaclotide) as a prescription medicine to ease constipation caused by irritable bowel syndrome (IBS-C) in children ages 7 years and older.