Drugs and Medications Approvals and Updates
- 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.
- 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.
- 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.
- 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.
- Dupixent: FDA Approves First and Only Medicine for Allergic Fungal Rhinosinusitis in Adults and Children Ages 6 Years and Older
February 25, 2026 — The FDA has approved Dupixent (dupilumab) for treating adults and children (ages 6 years and older) with allergic fungal sinus infections (AFRS) who have had sinus surgery.
- 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).
- 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.
- 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).
- 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.
- 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.