September 21, 2026 â The FDA has approved Aqneursa (levacetylleucine) for the treatment of ataxia in adults and pediatric patients with ataxia-telangiectasia who weigh at least 15 kilograms (33 pounds).
September 21, 2026 â The FDA has approved Fayuvi (rebisufligene etisparvovec) for the treatment of neurologic manifestations of mucopolysaccharidosis type IIIA (MPS IIIA), also called Sanfilippo syndrome type A, in pediatric patients with preserved neurodevelopmental function.
September 17, 2026 â The FDA has approved Kerendia (finerenone) to treat chronic kidney disease in adults with type 1 diabetes.
September 14, 2026 â The FDA has expanded the approval of Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in children ages 4 to 11 years who weigh at least 27 kilograms (about 60 pounds).
September 14, 2026 â The FDA has approved Isembyld (apitegromab) for spinal muscular atrophy (SMA) in adults and children 2 years of age and older who are currently receiving an SMN2-targeted treatment.
September 14, 2026 â The FDA has approved Hyrnuo (sevabertinib) as a first-line treatment for adults with locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations.
September 8, 2026 â The FDA has approved Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with an ESR1 mutation.
September 4, 2026 â The FDA has approved Zanvastro (zilganersen) for the treatment of Alexander disease in children and adults.
September 1, 2026 â The FDA has approved Mimrylo (rusfertide) for erythrocytosis in adults with polycythemia vera.
September 1, 2026 â The FDA has approved Besremi (ropeginterferon alfa-2b) for essential thrombocythemia.
August 31, 2026 â The FDA has approved Mounjaro (tirzepatide) to lower the risk of major cardiovascular events, such as heart attack, stroke, or cardiovascular death, in adults with type 2 diabetes who are at high risk for these events.
August 28, 2026 â The FDA has approved Bixlenvo (bictegravir and lenacapavir) for the treatment of HIV-1 infection in adults to replace their current HIV-1 medicines when their viral load is suppressed.
August 28, 2026 â The FDA has approved Lisraya (brepocitinib) for the treatment of dermatomyositis in adults.
August 26, 2026 â The FDA has approved Rasonque (daraxonrasib) for adults with advanced pancreatic cancer who have already had prior treatment or cannot receive certain strong combination therapies.
August 25, 2026 â The FDA has approved Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia in adults and pediatric patients ages 12 and older.
August 25, 2026 â The FDA has approved Ziihera (zanidatamab-hrii) in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr, for the first-line treatment of adult patients with HER2-positive advanced or metastatic gastroesophageal adenocarcinoma.
August 20, 2026 â The FDA has approved Genglycos (pariglasgene brecaparvovec) as an adjunct to nutritional management in patients 8 and older with glycogen storage disease type 1a (GSD1a).
August 19, 2026 â The FDA has approved Pasatru (garetosmab-grts) to reduce new abnormal bone growth outside the skeleton and reduce disease flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).
August 14, 2026 â The FDA has approved Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior therapy.
August 12, 2026 â The FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 in adult patients.
August 10, 2026 â The FDA has approved Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with advanced skin cancer (cutaneous melanoma) that cannot be removed by surgery and has gotten worse after previous treatment.
August 7, 2026 â The FDA has approved the mFlusiva (influenza vaccine, mRNA) to prevent the flu in adults ages 50 and older.
August 6, 2026 â The FDA has approved Mucinex 12HR Cold & Fever Multi-Symptom (guaifenesin, dextromethorphan hydrobromide, and naproxen sodium) for relieving symptoms of the common cold and flu, including cough, chest congestion, fever, headache, and body aches.
August 3, 2026 â Learn about the FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) combined with hormone therapy for prostate-specific membrane antigen (PSMA)-positive metastatic hormone sensitive prostate cancer.
July 30, 2026 â The FDA has approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system) for the prevention of pregnancy in women with a body mass index (BMI) under 30.
July 28, 2026 â The FDA has approved a new combination pill, Tylenol with Naproxen (acetaminophen and naproxen), for the temporary relief of minor aches and pains.
July 27, 2026 â The FDA has approved Simtriyo (centanafadine) for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older who weigh at least 20 kilograms (44 pounds).
July 27, 2026 â The FDA has approved Lytenava (bevacizumab) as an eye injection for neovascular (wet) age-related macular degeneration.
July 24, 2026 â This article provides information for patients about the FDA approval of Furoscix ReadyFlow, an at-home subcutaneous autoinjector used to treat fluid buildup in adults with chronic heart failure or chronic kidney disease.
July 23, 2026 â The FDA has approved Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer who received a prior ROS1 kinase inhibitor medicine.
July 22, 2026 â The FDA has approved Ryaltris (olopatadine/mometasone) for treating seasonal allergic rhinitis in children ages 6-11 years.
July 17, 2026 â User Description: The FDA has approved Lipfendra (enlicitide) as a daily pill to help lower bad cholesterol in adults with high cholesterol, including those with an inherited form of the condition.
July 15, 2026 â The FDA has approved Revtorpyk (gedatolisib) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer without a PIK3CA mutation.
July 14, 2026 â The FDA has modified the approval of Leqembi (lecanemab-irmb) to include an at-home starting dose to treat adults with Alzheimer's disease.
July 13, 2026 â The FDA has approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv) for adults with muscle invasive bladder cancer.
July 13, 2026 â The FDA has approved Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) for routine prophylaxis to reduce the frequency of bleeding episodes in pediatric patients with von Willebrand disease (VWD) who are younger than 6 years of age.
July 13, 2026 â The FDA has approved Sarclisa Escena (isatuximab-irfc) for use in combination with other cancer treatments in adults with multiple myeloma.
July 8, 2026 â User Description The FDA has approved Trutakna (atacicept) for reducing proteinuria in adults with primary immunoglobulin A (IgA) nephropathy who are at risk of disease progression.
July 6, 2026 â The FDA has expanded the approval of Casgevy (exagamglogene autotemcel), a one-time, autologous CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent beta-thalassemia in children as young as 2 years, making it the only genetic therapy authorized in the United States for this patient group.
July 2, 2026 â The FDA has approved Tregzi, a donor-derived regulatory T-cell therapy, to be used with matched-donor allogeneic stem cell transplant after myeloablative conditioning to help certain adults with blood cancers live longer without chronic graft-versus-host disease.
July 1, 2026 â The FDA has expanded the use of Zoryve (roflumilast) cream 0.3%, a once-daily, steroid-free medicine, for the treatment of plaque psoriasis on the skin, including in sensitive areas with skin folds, in children as young as 2 years old.
June 29, 2026 â The FDA has expanded the label for Skyrizi (risankizumabârzaa), an ILâ23 p19-targeting biologic, to treat moderate-to-severe plaque psoriasis or active psoriatic arthritis in children aged 6 years or older. This update makes Skyrizi the first ILâ23 inhibitor in the U.S. approved for pediatric use, with dosing for kids under 40 kg provided via a new 55-mg prefilled syringe and those weighing 40 kg or more using 150-mg devices.
June 29, 2026 â The FDA has approved Lumvoa (veligrotug-vvze), an intravenous therapy targeting the insulin-like growth factor-1 receptor, for the treatment of thyroid eye disease regardless of disease activity or duration (active or chronic).
June 26, 2026 â The FDA has approved Ibrance (palbociclib) combined with trastuzumab, with or without pertuzumab, plus endocrine therapy as ongoing maintenance treatment for adults with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer whose disease is controlled after induction therapy with a taxane and antiâHER2 therapy.
June 25, 2026 â The FDA has approved sacituzumab govitecan-hziy (Trodelvy) to treat adults with certain types of triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy and, in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), to treat adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1.
June 25, 2026 â The FDA has approved Tryngolza (olezarsen), used with diet, to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.
June 23, 2026 â The FDA has granted full approval and expanded the use of Tecelra (afamitresgene autoleucel), a personalized engineered T-cell therapy, to include patients 12 or older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, whose tumors express MAGE-A4, and who carry HLA-A*02 variants confirmed by FDA-approved tests.
June 18, 2026 â The FDA has expanded the use of Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to people 2 to 17 years old who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that increase their risk of pneumococcal disease, making Capvaxive the only PCV indicated and studied in the U.S. for use in this patient population.
June 17, 2026 â The FDA has approved Utebzi, an oral antibiotic to treat complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain bacteria in adults who have limited or no alternative oral treatment options. This is the first and only oral carbapenem antibiotic approved for these patients.