Drugs and Medications Approvals and Updates
- 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.
- 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 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Asceniv: FDA Extends Use of Intravenous Immunoglobulin for Primary Humoral Immunodeficiency in Children 2 and Older
May 5, 2026 — The FDA has expanded the use of Asceniv (intravenous immunoglobulin) to treat primary humoral immunodeficiency in children as young as 2 years old, based on studies showing that it prevents serious bacterial infections.
- Veppanu (Vepdegestrant): An Oral Protein Degrader for Certain ER+/HER2- Advanced Breast Cancers
May 4, 2026 — The FDA approved Veppanu (vepdegestrant) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, with disease progression following at least one line of endocrine therapy and as detected by an FDA-authorized test. It is the first time the FDA has approved a proteolysis targeting chimera (PROTAC), a type of heterobifunctional protein degrader therapy.
- Auvelity: FDA Expands Auvelity Use: First Non-Antipsychotic Option for Agitation in Alzheimer’s Dementia (Also Indicated for Adult MDD)
May 1, 2026 — The FDA approved an expanded use for Auvelity extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. It is the first FDA-approved treatment for this condition that is not an antipsychotic. The drug was initially approved in 2022 to treat major depressive disorder in adults.
- Breztri Aerosphere: FDA Approves Single-Inhaler Triple Therapy for Maintenance Control of Asthma in Patients Ages 12 Years or Older
April 29, 2026 — The FDA has approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) as the only single-inhaler triple therapy in the U.S. for maintenance control of asthma in patients ages 12 years or older.
- Caplyta (Lumateperone): FDA Updates Labeling for Once-Daily Antipsychotic to Help Prevent Relapse in Patients With Schizophrenia
April 28, 2026 — The FDA has updated labeling for Caplyta (lumateperone), a once-daily antipsychotic for adults, based on long-term data showing that it helps prevent schizophrenia relapse.
- Otarmeni: FDA Approves One-Time Gene Therapy for OTOF-Associated Genetic Hearing Loss
April 24, 2026 — The FDA has granted accelerated approval to Otarmeni (lunsotogene parvec-cwha), a one-time gene therapy delivered via cochlear infusion, for children and adults with severe to profound OTOF-associated sensorineural hearing loss.
- Tzield: FDA Expands Immune Therapy Use to Delay Stage III Type 1 Diabetes in Kids as Young as 1 Year Old
April 23, 2026 — The FDA has expanded approval of Tzield (teplizumab-mzwv) to delay the start of stage III type 1 diabetes (T1D) to include children as young as 1 year old who have stage II T1D, offering a 14-day IV course that can ease early childhood disease burden.
- Dupixent: FDA Approves First Under-the-Skin Biologic Shot for Children Ages 2-11 Years With Chronic Hives Not Controlled With Antihistamines
April 23, 2026 — The FDA has approved Dupixent (dupilumab) as the first subcutaneous biologic in the U.S. for children ages 2-11 years with chronic spontaneous urticaria who have symptoms despite the use of histamine‑1 antihistamines.
- Idvynso: FDA Approves New Once-Daily Combo Pill for Adults With HIV-1 Infection
April 22, 2026 — The FDA has approved Idvynso (doravirine/islatravir) as a once‑daily, complete single-tablet treatment regimen for adults with HIV‑1 infection.
- Filspari: FDA Approves Dual-Acting Oral Therapy for Focal Segmental Glomerulosclerosis
April 14, 2026 — Filspari (sparsentan) is a once-daily oral dual-acting therapy approved by the FDA for reducing urine protein in adults and children ages 8 years or older with focal segmental glomerulosclerosis without nephrotic syndrome.
- Eylea HD: FDA Allows Up to 5-Month Dosing With Higher-Strength Formulation for Vision-Threatening Eye Conditions
April 3, 2026 — The FDA has approved Eylea HD (aflibercept), a higher-strength anti-VEGF eye injection that allows eligible patients with wet age-related macular degeneration or diabetic macular edema to extend dosing to up to once in 20 weeks (about 5 months), potentially reducing injection frequency.
- FDA Warns of Serious Liver Injury Risks From Vasculitis Drug Tavneos
April 1, 2026 — The FDA has issued a safety alert for Tavneos, a medication used to treat a rare autoimmune disease, due to recent reports linking the drug to serious, and in some cases fatal, liver injuries.
- FDA Approves Foundayo, a New Once-Daily Pill for Weight Loss
April 1, 2026 — The FDA has approved Foundayo (orforglipron) as a once‑daily GLP-1 pill to help adults lose excess weight and keep it off long term.
- Awiqli: FDA Approves First and Only Once-Weekly Long-Acting Basal Insulin for Adults With Type 2 Diabetes
March 27, 2026 — The FDA has approved Awiqli, the first once‑weekly long‑acting basal insulin, for adults with type 2 diabetes, which offers convenient weekly dosing compared with daily basal insulin injections.
- Kresladi: FDA Approves First One-Time Gene Therapy for Children With Severe Leukocyte Adhesion Deficiency Type I
March 27, 2026 — The FDA granted accelerated approval to Kresladi, the first one-time autologous gene therapy for children with severe Leukocyte Adhesion Deficiency Type I, which adds a functional ITGB2 gene to the patient’s stem cells to restore CD18/CD11a expression and improve immune function.
- Safety Alert: Nationwide Recall Issued for Children's Ibuprofen
March 25, 2026 — Strides Pharma Inc. is recalling specific lots of Children's Ibuprofen Oral Suspension due to concerns about potential contamination.
- Lynavoy: FDA Approves First Treatment for Severe Itching in Adults With Primary Biliary Cholangitis
March 24, 2026 — The FDA has approved Lynavoy (linerixibat) as a prescription pill to treat cholestatic pruritus – a severe, chronic, internal itch – in adults with primary biliary cholangitis (PBC).
- Opdivo: FDA Approves Immunotherapy With Chemo for Previously Untreated Hodgkin Lymphoma
March 23, 2026 — The FDA has approved Opdivo to be used in combination with AVD chemotherapy (doxorubicin, vinblastine, and dacarbazine) for previously untreated stage III-IV classical Hodgkin lymphoma (cHL) in adults and adolescents aged 12 and older.
- Wegovy HD (Semaglutide 7.2 mg) Injection: FDA Clears a Higher-Dose Option for Long‑Term Weight Loss
March 20, 2026 — Wegovy HD is a new 7.2-milligram strength of semaglutide given once a week as an injection under the skin. It is approved to help adults lose excess weight and keep it off if you have obesity, or if you are overweight with at least one weight‑related health problem.
- Imcivree: FDA Approves Once-Daily Under-the-Skin Injection for Weight Loss in Patients With Acquired Hypothalamic Obesity
March 20, 2026 — Imcivree (setmelanotide), a shot that treats a rare type of obesity linked to Bardet-Biedl syndrome and certain genetic conditions, has been approved treat acquired hypothalamic obesity (HO) in adults and children ages 4 years and older.
- Icotyde (icotrokinra): First Oral IL-23 Inhibitor for Plaque Psoriasis
March 19, 2026 — The FDA has approved Icotyde (icotrokinra) as a once-daily pill for adults and those 12 and older who weigh at least 40 kilograms (about 88 pounds) and need a whole-body treatment or phototherapy for moderate to severe plaque psoriasis.
- Arexvy: FDA Expands Vaccine Use to Help Prevent RSV Lung Disease in At-Risk Adults
March 16, 2026 — The FDA has expanded the use of Arexvy to people 18 to 49 years old with health issues that raise their risk of lower respiratory tract disease (LRTD) caused by RSV.
- Cosentyx: FDA Approves Biologic Under-the-Skin Shot for Teens With Moderate-to-Severe Hidradenitis Suppurativa
March 16, 2026 — Cosentyx (secukinumab) is a fully human biologic medicine that targets and blocks interleukin‑17A (IL‑17A), a naturally occurring protein in the body that helps regulate the immune system and manage inflammation. The FDA has expanded the use of Cosentyx for treating children 12 and older with moderate-to-severe hidradenitis suppurativa (HS).
- Wellcovorin (Leucovorin Calcium): First Approved Treatment for FOLR1-Related Cerebral Folate Transport Deficiency
March 11, 2026 — The FDA has expanded the use of Wellcovorin (leucovorin calcium) to treat folate receptor 1‑related cerebral folate transport deficiency (FOLR1‑CFTD) in adults and children who have a confirmed change in the FOLR1 gene.
- Sotyktu: FDA Approves First Selective, Once-Daily Oral TYK2 Inhibitor for Adults With Active Psoriatic Arthritis
March 9, 2026 — The FDA has approved Sotyktu as the only TYK2 inhibitor for adults with active psoriatic arthritis.
- Tecvayli Plus Darzalex Faspro: FDA Approves Under‑the‑Skin Combo Immune Therapy as a New Second-Line Option for Multiple Myeloma
March 6, 2026 — The FDA has approved Tec-Dara – a combination of the drugs Tecvayli (teclistamab) and Darzalex Faspro (daratumumab and hyaluronidase) – to treat multiple myeloma in adults whose cancer has come back or did not respond to previous treatment.
- Palynziq (pegvaliase-pqpz): FDA Expands Enzyme Substitution Therapy to Adolescents 12+ With PKU to Help Lower Phenylalanine
March 3, 2026 — The FDA has expanded who can use Palynziq. It now includes adolescents 12 years and older with PKU whose Phe levels stay high despite care.
- Yuviwel (Navepegritide): Once-Weekly Shot to Help With Growth in Children With Achondroplasia
March 3, 2026 — Yuviwel (navepegritide), a once-weekly shot, has been approved to help increase height in children 2 and older with achondroplasia who still have open growth plates.
- Sogroya: Once-Weekly, Long-Acting Shot for Adults With Growth Hormone Deficiency and Children With Short Stature (GHD, SGA, Noonan Syndrome, ISS)
March 3, 2026 — Sogroya (somapacitan-beco), has been approved as a once-weekly shot to treat adults with growth hormone deficiency and children 2.5 years and older who have certain growth disorders.
- Hernexeos: FDA Approves First-Line Use for Certain Advanced Non-Small-Cell Lung Cancers With HER2 Mutations
February 27, 2026 — The FDA has approved Hernexeos (zongertinib) as a first-choice treatment for adults with non-small-cell lung cancer whose tumors have specific genetic changes, as confirmed by an FDA-authorized test.
- Desmoda: FDA Approves the First and Only Liquid Version of Desmopressin to Ensure Precise Dosing in Patients With Central Diabetes Insipidus
February 26, 2026 — The FDA has approved Desmoda (desmopressin acetate) oral solution for managing central diabetes insipidus (CDI) in adults and children.