Approvals and Updates
- 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 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 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 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.
- FDA Approves At-Home Starting Dose for Alzheimer's Drug Leqembi
July 14, 2026 — The FDA has modified the approval of Leqembi (lecanemab-irmb) to include an at-home starting dose to treat adults with Alzheimer's disease.
- FDA Approves Wilate to Help Prevent Bleeding in Young Children With von Willebrand Disease
July 13, 2026 — 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.
- Headline: FDA Approves Sarclisa Escena, an Under-the-Skin Injection for Multiple Myeloma
July 13, 2026 — The FDA has approved Sarclisa Escena (isatuximab-irfc) for use in combination with other cancer treatments in adults with multiple myeloma.
- FDA Approves Keytruda and Keytruda Qlex to Treat Bladder Cancer Before and After Surgery
July 13, 2026 — 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.
- Trutakna: A New Weekly Shot to Help Adults With IgA Nephropathy
July 8, 2026 — 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.
- Casgevy: FDA Expands One-Time Gene Therapy for Sickle Cell Disease and Beta Thalassemia to Children as Young as 2 Years
July 6, 2026 — 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.
- Tregzi: FDA Approves Donor Immune Cell Therapy to Lower the Risk of Serious Problems in Adults With Blood Cancer
July 2, 2026 — 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.
- Zoryve Cream: FDA Expands Approval for Once-Daily Topical for Plaque Psoriasis in Children Aged 2 or Older
July 1, 2026 — 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.
- Skyrizi: FDA Approves Pediatric Expansion of IL‑23 Inhibitor for Moderate-to-Severe Plaque Psoriasis and Active Psoriatic Arthritis
June 29, 2026 — The FDA has expanded the label for Skyrizi (risankizumab‑rzaa), an IL‑23 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 IL‑23 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.
- Lumvoa: FDA Approves New Intravenous Treatment for Both Active and Chronic Thyroid Eye Disease
June 29, 2026 — 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).
- Ibrance: FDA Approves Oral Targeted Therapy With Anti‑HER2 and Endocrine Therapy for HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
June 26, 2026 — 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 anti‑HER2 therapy.
- Trodelvy (sacituzumab govitecan-hziy): First-Line Treatment for Triple-Negative Breast Cancer and an Antibody-Drug Conjugate Option for Certain Advanced Breast Cancers
June 25, 2026 — 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.
- FDA Approves Tryngolza, First Treatment to Reduce Acute Pancreatitis Risk in Severe Hypertriglyceridemia
June 25, 2026 — The FDA has approved Tryngolza (olezarsen), used with diet, to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.
- Tecelra: FDA Expands T-Cell Therapy to Include Patients as Young as 12 Years Old With Advanced Synovial Sarcoma
June 23, 2026 — 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.
- Capvaxive: 21-Valent Pneumococcal Conjugate Vaccine Adds Broader Strain Coverage and a New FDA Indication for High-Risk Children and Teens
June 18, 2026 — 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.
- Utebzi: First oral carbapenem for complicated urinary tract infections in adults
June 17, 2026 — 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.
- FDA Approves Tzield to Slow the Decline of Natural Insulin Production in People 8-17 Years Old With Newly Diagnosed Stage 3 Type 1 Diabetes
June 15, 2026 — The FDA has granted accelerated approval for Tzield (teplizumab‑mzwv), an intravenous anti‑CD3 monoclonal antibody, to slow the decline in natural insulin production in children aged 8-17 years newly diagnosed with stage 3 type 1 diabetes.
- Welireg With Keytruda or Keytruda Qlex: FDA Approves Adjuvant Therapy Combination for Certain Adults With Clear Cell Renal Cell Carcinoma After Surgery
June 15, 2026 — The FDA has approved Welireg (belzutifan) for use with Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) as adjuvant therapy after surgery for adults with clear cell renal cell carcinoma who have an intermediate‑to‑high or high risk of cancer recurrence, including patients with resected metastases and no evidence of disease.
- FDA Approves Truqap as the First Targeted Therapy for PTEN-Deficient Metastatic Prostate Cancer
June 15, 2026 — The FDA has approved Truqap (capivasertib) as the first targeted therapy for PTEN-deficient metastatic androgen pathway modulation-naive or sensitive (mAPMN/S) prostate cancer. It’s taken with abiraterone and prednisone for adults whose tumors show PTEN loss on an FDA-authorized test.
- Ebglyss: FDA Approves Once-Every-8-Week Maintenance Injection Option for Moderate to Severe Eczema in Adults and Children Ages 12 Years and Older
June 10, 2026 — The FDA has approved an expanded maintenance dosing option for the biologic Ebglyss (lebrikizumab-lbkz) for treating moderate to severe atopic dermatitis (eczema) in adults and adolescents ages 12 years and older who weigh at least 40 kilograms (88 pounds). After the initial treatment period, responders may transition to a lower-frequency dosing plan of one subcutaneous injection every eight weeks (instead of every four weeks) for maintaining disease control. Ebglyss can be used alone or with topical corticosteroids and targets interleukin-13 to help reduce inflammation and symptoms.
- FDA Approves New Sunscreen Active Ingredient for Broad UV Protection
June 10, 2026 — The FDA has added bemotrizinol as an active ingredient to the U.S. over-the-counter (OTC) sunscreen monograph, allowing its use in OTC sunscreens for adults and children aged 6 months and older. Bemotrizinol provides broad-spectrum protection against UVA and UVB rays.
- Hympavzi: Once‑Weekly, Single‑Dose Under‑the‑Skin Shot to Help Prevent Bleeding in Hemophilia A or B (ages 6+)
June 9, 2026 — The FDA has approved an expanded indication for Hympavzi (marstacimab-hncq) to include the treatment of patients 12 and older with hemophilia A or B with inhibitors and patients ages 6 to 11 with or without inhibitors.
- Cavhanza (Nilotinib): FDA Approves Orally Disintegrating Tablet for Adults With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
June 3, 2026 — The FDA has approved Cavhanza (nilotinib), a new orally disintegrating tablet, for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). It is designed for easier, more flexible dosing with consistent absorption, including when taken with food or common acid‑reducing medicines. It is indicated for newly diagnosed chronic‑phase Ph+ CML and those with chronic- or accelerated-phase disease who are resistant or intolerant to prior therapy.
- Zaynich: FDA Approves New IV Antibiotic for Complicated Urinary Tract Infections in Adults
June 2, 2026 — The FDA has approved Zaynich (cefepime and zidebactam) as an intravenous antibiotic for adults with complicated urinary tract infections, including kidney infections, caused by certain resistant Gram-negative bacteria.
- Xocova: FDA Approves First Oral Post-Exposure Prophylaxis to Help Prevent COVID-19 in Adults and Adolescents 12 and Older
June 2, 2026 — The FDA has approved Xocova (ensitrelvir), the first oral post‑exposure prophylaxis (PEP) to help prevent COVID‑19 in adults and adolescents 12 and older.
- Afrezza: FDA Clears Use for Children 6 and Older With Type 1 or Type 2 Diabetes
June 1, 2026 — The FDA has approved expanded use of MannKind's inhaled rapid-acting insulin in children with diabetes, offering patients under 18 years of age a needle-free treatment option.
- FDA Expands Tremfya Label to Highlight Protection Against Joint Damage in Psoriatic Arthritis
May 29, 2026 — The FDA has expanded the label for Tremfya, highlighting new evidence that it can help slow or stop joint damage in adults with active psoriatic arthritis.
- Imfinzi: FDA Approves Immunotherapy Plus BCG Combination for High-Risk Early Non-Muscle-Invasive Bladder Cancer
May 29, 2026 — The FDA has approved Imfinzi (durvalumab), a PD L1-blocking immunotherapy medicine, in combination with BCG therapy for adults with BCG naive, high risk non-muscle invasive bladder cancer, making it the first immunotherapy plus BCG option for this early, curative intent setting.
- FDA Approves Decnupaz, First Antibody-Drug Conjugate for Blastic Plasmacytoid Dendritic Cell Neoplasm
May 28, 2026 — The FDA has approved Decnupaz (pivekimab sunirine) for the treatment of adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- FDA Clears Once-Daily Linzess Capsule for Functional Constipation in Children Ages 2 Years and Older
May 28, 2026 — The FDA has expanded the indication for linaclotide (Linzess) to treat functional constipation (FC) in children ages 2-5 years, making it the first FDA‑approved prescription option for FC in this age group.
- Datroway: FDA Approves Antibody-Drug Conjugate Injection for Advanced Triple-Negative Breast Cancer
May 26, 2026 — The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate, for first-line treatment of unresectable or metastatic triple-negative breast cancer in adults who are not eligible for PD-1/PD-L1 immunotherapy.
- Trimbow: A Triple-Combination Inhaler for Asthma Maintenance in Adults
May 19, 2026 — The FDA has approved Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) to prevent and control symptoms of asthma in adults.
- Fasenra: FDA Approves Under-the-Skin Shot to Help Reduce Flares in Hypereosinophilic Syndrome
May 19, 2026 — The FDA has approved Fasenra (benralizumab) to help reduce flares in hypereosinophilic syndrome (HES) for adults and children ages 12 or older who have no other non-blood-related cause.
- Tecentriq and Tecentriq Hybreza: FDA Approves First ctDNA‑Guided Adjuvant Immunotherapies to Target Residual Muscle‑Invasive Bladder Cancer After Surgery
May 19, 2026 — The FDA has approved Tecentriq and Tecentriq Hybreza as the first circulating tumor DNA (ctDNA)‑guided adjuvant immunotherapies for adults with muscle‑invasive bladder cancer after cystectomy when an FDA‑authorized blood test detects ctDNA, indicating molecular residual disease. The FDA has also cleared Signatera CDx to identify eligible patients.
- Baxfendy: A New Option for Uncontrolled High Blood Pressure
May 18, 2026 — The FDA has approved Baxfendy (baxdrostat) for use in combination with other antihypertensives to lower blood pressure in adults who do not have adequately controlled blood pressure.
- Enhertu: FDA Clears New Pre- and Post-Surgery Uses in HER2-Positive Early Breast Cancer
May 18, 2026 — The FDA has cleared new neoadjuvant and adjuvant uses for Enhertu (fam-trastuzumab deruxtecan-nxki) in adults with HER2-positive early breast cancer, positioning the medicine earlier in care.
- Beqalzi: FDA Approves New Oral BCL-2 Blocker for Relapsed or Refractory Mantle Cell Lymphoma
May 14, 2026 — The FDA has granted accelerated approval to Beqalzi (sonrotoclax), an oral BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least two prior therapies, including a BTK inhibitor.
- Inqovi: FDA Approves First All‑Oral Regimen for Certain Patients With Newly Diagnosed Acute Myeloid Leukemia
May 14, 2026 — The FDA has approved the all-oral combination of Inqovi (decitabine and cedazuridine) with venetoclax for adults with newly diagnosed acute myeloid leukemia who are 75 or older or ineligible for intensive induction chemotherapy.
- Bizengri: FDA Approves Second-Line Intravenous Treatment for Adults With NRG1 Fusion-Positive, Advanced, Surgically Unresectable, Metastatic Bile Duct Cancer
May 13, 2026 — The FDA has approved Bizengri (zenocutuzumab-zbco) for adults with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma that has worsened after prior therapy.
- Vyvgart: FDA Expands Label to Include All Adults With Generalized Myasthenia Gravis
May 12, 2026 — The FDA expanded the labels for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) to include all adults with generalized myasthenia gravis (gMG), regardless of antibody status (anti-AChR, anti-MuSK, anti-LRP4, or seronegative).
- Ocrevus: FDA Approves Intravenous Targeted Therapy for Children Aged 10 Years or Older With Relapsing-Remitting Multiple Sclerosis
May 12, 2026 — The FDA has approved Ocrevus (ocrelizumab) for relapsing-remitting multiple sclerosis in pediatric patients aged 10 years or older who weigh at least 55 pounds.