Approvals and Updates
- FDA Approves Hibsago: A New Treatment for Chronic Hepatitis B
October 22, 2026 — The FDA has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B virus infection in adult patients without cirrhosis.
- FDA Approves Jemperli for Certain Types of Rectal Cancer
October 22, 2026 — The FDA has approved Jemperli (dostarlimab) for adults with stage II or stage III locally advanced rectal cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
- FDA Approves Enspryng At-Home Shot for Thyroid Eye Disease
October 16, 2026 — The FDA has approved Enspryng (satralizumab) for thyroid eye disease (TED).
- FDA Approves Hovilpri for Hard-to-Treat Herpes Lesions in People With Weak Immune Systems
October 13, 2026 — The FDA has approved Hovilpri (pritelivir) to treat resistant herpes simplex virus (HSV) lesions in adults with weakened immune systems.
- FDA Approves Tecentriq Combination for Stage III Colon Cancer
October 12, 2026 — The FDA has approved Tecentriq (atezolizumab) in combination with chemotherapy (a fluoropyrimidine and oxaliplatin) for the adjuvant treatment of adult and pediatric patients aged 2 years or older with stage III mismatch repair deficient (dMMR) colon cancer.
- FDA Approves Tukysa Maintenance Treatment for HER2-Positive Metastatic Breast Cancer
October 8, 2026 — The FDA has approved Tukysa (tucatinib) combined with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer after induction treatment.
- FDA Approves Rhapsido for People With Hives Triggered by Skin Rubbing
October 8, 2026 — The FDA has approved Rhapsido (remibrutinib) for adults with symptomatic dermographism who remain symptomatic despite use of H1 antihistamines.
- FDA Approves Jaypirca for First-Time Treatment of Certain Blood Cancers
October 6, 2026 — The FDA has approved Jaypirca (pirtobrutinib) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a 17p deletion.
- FDA Approves Atebrioz to Reduce Extra Bone Growth in Rare Gene Disorder
October 1, 2026 — The FDA has approved Atebrioz (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification in adults and pediatric patients aged 12 years or older with fibrodysplasia ossificans progressiva.
- FDA Approves Gazyva to Help Prevent Kidney Disease Relapses in Adults and Children Aged 2 or Older
September 30, 2026 — The FDA has approved Gazyva (obinutuzumab) to reduce the risk of disease relapse in adults and children aged 2 years or older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission.
- FDA Approves Olumiant for Teens With Severe Hair Loss
September 29, 2026 — The FDA has approved Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata.
- FDA Approves Juvmo to Help Adults Manage Parkinson’s Disease
September 29, 2026 — The FDA has approved Juvmo (tavapadon) for the treatment of Parkinson disease in adults.
- FDA Approves Emcitate to Treat Rare Thyroid Condition in Adults and Children
September 29, 2026 — The FDA has approved Emcitate (tiratricol) for peripheral thyrotoxicosis in adults and children with monocarboxylate transporter 8 (MCT8) deficiency.
- FDA Approves Lenvima Plus Welireg for Advanced Kidney Cancer
September 28, 2026 — The FDA has approved Lenvima (lenvatinib) in combination with Welireg (belzutifan) for adults with advanced renal cell carcinoma with a clear cell component following treatment with a PD-1 or PD-L1 inhibitor.
- FDA Approves Lyrfigtu for Advanced Bile Duct Cancer
September 28, 2026 — The FDA has approved Lyrfigtu (lirafugratinib) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with an FGFR2 gene fusion or other rearrangement.
- FDA Approves Onswik, a Once-Weekly Insulin Shot for Type 2 Diabetes
September 25, 2026 — The FDA has approved Onswik (insulin efsitora alfa) to help lower blood sugar in adults with type 2 diabetes.
- FDA Approves Aqneursa to Help Improve Muscle Control in Ataxia-Telangiectasia
September 21, 2026 — 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).
- FDA Approves Fayuvi, First Gene Therapy for Children With Sanfilippo Syndrome Type A
September 21, 2026 — 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.
- FDA Approves Kerendia for Adults With Type 1 Diabetes and Kidney Disease
September 17, 2026 — The FDA has approved Kerendia (finerenone) to treat chronic kidney disease in adults with type 1 diabetes.
- FDA Approves Joenja for Younger Children With Rare Immune Disease
September 14, 2026 — 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).
- FDA Approves Isembyld to Help Improve Muscle Strength in Spinal Muscular Atrophy
September 14, 2026 — 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.
- FDA Approves Hyrnuo as First Treatment Choice for Specific Type of Lung Cancer
September 14, 2026 — 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.
- FDA Approves Etcamah Combination for Advanced Breast Cancer
September 8, 2026 — 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.
- FDA Approves Zanvastro for Rare Brain Disorder Alexander Disease
September 4, 2026 — The FDA has approved Zanvastro (zilganersen) for the treatment of Alexander disease in children and adults.
- FDA Approves Mimrylo for Polycythemia Vera
September 1, 2026 — The FDA has approved Mimrylo (rusfertide) for erythrocytosis in adults with polycythemia vera.
- FDA Approves Besremi for Adults With Rare Blood Disorder
September 1, 2026 — The FDA has approved Besremi (ropeginterferon alfa-2b) for essential thrombocythemia.
- FDA Approves Mounjaro to Help Lower Heart Attack and Stroke Risk in Adults With Type 2 Diabetes
August 31, 2026 — 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.
- FDA Approves Bixlenvo, a New Daily Pill to Treat HIV
August 28, 2026 — 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.
- FDA Approves Lisraya, an Oral Pill to Treat Adults With Dermatomyositis
August 28, 2026 — The FDA has approved Lisraya (brepocitinib) for the treatment of dermatomyositis in adults.
- FDA Approves Rasonque for Advanced Pancreatic Cancer
August 26, 2026 — 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.
- FDA Approves Imaavy for Warm Autoimmune Hemolytic Anemia
August 25, 2026 — The FDA has approved Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia in adults and pediatric patients ages 12 and older.
- FDA Approves Ziihera Combinations for Advanced Stomach and Esophageal Cancers
August 25, 2026 — 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.
- FDA Approves Genglycos, First Gene Therapy for Glycogen Storage Disease Type 1a
August 20, 2026 — 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).
- FDA Approves Pasatru for Adults With Rare Bone Disease
August 19, 2026 — 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).
- FDA Approves Zenbexus Combination for Multiple Myeloma
August 14, 2026 — 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.
- FDA Approves Orzeyful (Oveporexton) for Adults With Narcolepsy Type 1
August 12, 2026 — The FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 in adult patients.
- FDA Approves Tudriqev for Advanced Skin Cancer
August 10, 2026 — 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.
- FDA Approves mFlusiva, the First mRNA Flu Vaccine for Older Adults
August 7, 2026 — The FDA has approved the mFlusiva (influenza vaccine, mRNA) to prevent the flu in adults ages 50 and older.
- FDA Approves Mucinex 12HR Cold & Fever Multi-Symptom for Cold and Flu Relief
August 6, 2026 — 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.
- FDA Approves Pluvicto for Early-Stage Metastatic Prostate Cancer
August 3, 2026 — 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.
- FDA Approves Gwyn Lo, a New Low-Dose Weekly Birth Control Patch
July 30, 2026 — 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.
- Tylenol With Naproxen: New Over-the-Counter Pill for 12-Hour Pain Relief
July 28, 2026 — The FDA has approved a new combination pill, Tylenol with Naproxen (acetaminophen and naproxen), for the temporary relief of minor aches and pains.
- FDA Approves Simtriyo, a New Type of Stimulant, for Adults and Children With ADHD
July 27, 2026 — 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).
- FDA Approves Lytenava Eye Injection for Wet Age-Related Macular Degeneration
July 27, 2026 — The FDA has approved Lytenava (bevacizumab) as an eye injection for neovascular (wet) age-related macular degeneration.
- FDA Approves Furoscix ReadyFlow, a Quick at-Home Injection for Fluid Buildup
July 24, 2026 — 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.
- FDA Approves Jideytro for Advanced ROS1-Positive Lung Cancer
July 23, 2026 — 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.
- Ryaltris Nasal Spray Now Approved for Kids Ages 6-11 With Seasonal Allergies
July 22, 2026 — The FDA has approved Ryaltris (olopatadine/mometasone) for treating seasonal allergic rhinitis in children ages 6-11 years.
- FDA Approves Lipfendra, the First Daily Pill of Its Kind to Lower Bad Cholesterol
July 17, 2026 — 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.
- FDA Approves Revtorpyk to Help Treat Certain Form Advanced Breast Cancer
July 15, 2026 — 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.