Drugs and Medications Approvals and Updates
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
- Accrufer: FDA Expands Use of Oral Iron Treatment for Kids Ages 10 and Older
December 23, 2025 — The FDA has approved Accrufer (ferric maltol), an oral capsule, to treat iron deficiency in kids ages 10 years and older, providing an option that doesn’t involve getting iron through an injection or intravenous (IV) line.
- FDA Approves Once-Daily Wegovy Pill as the First Oral GLP-1 Medicine for Weight Loss in Adults With Obesity or Overweight
December 23, 2025 — The FDA has approved the oral pill form of Wegovy (semaglutide), to be used along with a low-calorie diet and increased physical activity, to help adults with obesity, or those who are overweight with weight-related medical conditions, lose weight and keep it off.
- 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.
- Fesilty: FDA Approves New Treatment Option for Rare Bleeding Disorder
December 22, 2025 — The FDA has approved Fesilty (fibrinogen, human-chmt) to treat sudden bleeding episodes in children and adults who have a rare condition called congenital fibrinogen deficiency, or CFD.
- FDA Expands Jascayd Approval to Adults With Progressive Pulmonary Fibrosis
December 22, 2025 — The FDA has approved Jascayd (nerandomilast) as a treatment for adults with progressive pulmonary fibrosis (PPF) that causes gradual and permanent scarring in the lungs, making it harder to breathe over time.
- FDA Approves Myqorzo, a New Oral Therapy for Obstructive Hypertrophic Cardiomyopathy
December 22, 2025 — The FDA approves Myqorzo (aficamten) as a new oral medicine for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). It relieves symptoms, improves heart function, and provides stamina for daily activities.
- FDA Approves Rybrevant Faspro: An Under-the-Skin Injection for Use in Combination With Lazcluze for EGFR-Mutated Lung Cancer
December 18, 2025 — The FDA has approved Rybrevant Faspro in combination with another medicine called lazertinib (Lazcluze) as a first-line treatment for a type of lung cancer called non-small-cell lung cancer (NSCLC) that has certain genetic changes (mutations) in the EGFR (epidermal growth factor receptor) gene.
- Exdensur: FDA Approves New Twice-Yearly Medicine for Severe Asthma
December 18, 2025 — Exdensur (depemokimab) is a new type of ultra long-acting biologic medicine approved by the FDA as an add-on maintenance treatment for severe eosinophilic asthma.
- Enhertu Plus Pertuzumab: New First-Line Option for Advanced HER2-Positive Metastatic Breast Cancer
December 17, 2025 — Enhertu (fam-trastuzumab deruxtecan-nxki) is a type of targeted cancer treatment called an antibody-drug conjugate. The FDA has approved it in combination with another medicine, pertuzumab, as the first-line treatment for adults with HER2-positive breast cancer that has spread (metastatic) or cannot be removed with surgery (unresectable).
- FDA Approves Lerochol: A Monthly Injectable Treatment to Reduce High LDL Cholesterol Levels in Adults
December 17, 2025 — Lerochol (lerodalcibep-liga) is a new medicine approved by the FDA to help lower elevated levels of low-density lipoprotein cholesterol (LDL-C), often called “bad cholesterol,” in adults with hypercholesterolemia (high cholesterol levels), including those with a genetic form called heterozygous familial hypercholesterolemia (HeFH).
- Addyi: FDA Approves New Treatment for Low Sexual Desire in Postmenopausal Women
December 17, 2025 — Addyi (flibanserin) is a nonhormonal prescription pill that is now approved by the FDA to treat low sexual desire in women younger than 65, including those who are postmenopausal.