As April begins, we’re taking a look at the FDA approvals for the first three months of 2026. Last quarter saw more than forty medications approved: Six in January, 19 in February, and 17 in March, for a total of 42 approvals across the three month period. Below, we have each approval sorted, with accompanying generic form and indication provided.

The following is a consolidated list of all the FDA-approved medications from January through March 2026.

January 2026
  • Zycubo (copper histidinate)
    • For the treatment of Menkes disease.
  • Filkri (filgrastim-laha)
    • Multiple indications as a biosimilar to Neupogen.
  • Nexplanon (etonogestrel implant)
    • For use by women of reproductive potential to prevent pregnancy for up to five years (expanded from three years).
  • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    • In combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility.
  • Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution)
    • For the treatment of presbyopia in adults.
  • Ozempic (semaglutide)
    • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
February 2026
  • Vybrique (sildenafil)
    • To treat men aged 18 years and older with erectile dysfunction.
  • Yescarta (axicabtagene ciloleucel)
    • Updated indication removing the previous limitations of use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).
  • Keytruda (pembrolizumab)
    • For the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens.
  • Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)
    • Plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens.
  • Optune Pax (N/A)
    • For the treatment of patients with locally advanced pancreatic cancer, in combination with gemcitabine and nab-paclitaxel.
  • Adquey (difamilast)
    • For the treatment of mild to moderate atopic dermatitis in patients two years of age and older.
  • Wakix (pitolisant)
    • For the treatment of cataplexy in patients six years of age and older with narcolepsy.
  • Enzeevu (aflibercept-abzv)
    • Expanded to include patients with macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR), and diabetic macular edema (DME).
  • Calquence (acalabrutinib + venetoclax)
    • In combination with venetoclax for the first-line treatment of adults with chronic lymphocytic leukemia (CLL), including small lymphocytic lymphoma.
  • Bysanti (milsaperidone)
    • For the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.
  • Elucirem (gadopiclenol)
    • Expanded to include neonates and infants, in addition to adults and pediatric patients, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
  • Vueway (gadopiclenol)
    • Expanded to include neonates and infants, in addition to adults and pediatric patients, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)
  • Loargys (pegzilarginase-nbln)
    • For the treatment of hyperargininemia in adult and pediatric patients two years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction.
  • Dupixent (dupilumab)
    • For the treatment of adult and pediatric patients aged six years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.
  • Desmoda (desmopressin acetate)
    • For the management of central diabetes insipidus as antidiuretic replacement therapy for patients of all ages.
  • Hernexeos (zongertinib)
    • For the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
  • Yuviwell (navepegritide)
    • To increase linear growth in children two years and older with achondroplasia with open epiphyses.
  • Sogroya (somapacitan-beco)
    • For children aged 2.5 years and older with idiopathic short stature (ISS), short stature born small for gestational age (SGA) with no catch-up growth by two years of age, or growth failure associated with Noonan syndrome (NS)
  • Palynziq (pegvaliase-pqpz)
    • Expanded to include pediatric patients 12 years of age and older with phenylketonuria (PKU).
March 2026
  • Juxtapid (lomitapide)
    • For the treatment of patients two years of age and older with homozygous familial hypercholesterolemia.
  • Tecvayli + Darzalex Faspro (teclistamab-cqyv + daratumumab and hyaluronidase-fihj)
    • For the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
  • Sotyktu (deucravacitinib)
    • For the treatment of adults with active psoriatic arthritis.
  • Pylarify TruVu (piflufolastat F 18)
    • For positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
  • Wellcovorin (leucovorin)
    • For the treatment of adults and children with cerebral folate deficiency and a confirmed variant in the folate receptor 1 gene (CFD-FOLR1), an ultra-rare brain disorder that can resemble autism.
  • Arexvy (respiratory syncytial virus vaccine [adjuvanted])
    • Expanded to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV.
  • Cosentyx (secukinumab)
    • For patients 12 years and older with moderate to severe hidradenitis suppurativa (HS).
  • Icotyde (icotrokinra)
    • For the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.
  • Wegovy HD (semaglutide)
    • For weight loss and long-term maintenance of weight loss for certain adult patients.
  • Lynavoy (linerixibat)
    • For the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis.
  • Imcivree (setmelanotide)
    • To treat acquired hypothalamic obesity (HO) in adults and pediatric patients aged four years and older.
  • Opdivo (nivolumab)
    • With doxorubicin, vinblastine, and dacarbazine (AVD) chemotherapy for the first-line treatment of patients aged 12 years and older with stage III or IV classic Hodgkin lymphoma.
  • Lifyorli (relacorilant)
    • In combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
  • Avlayah (tividenofusp alfa-eknm)
    • For the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.
  • Kresladi (marnetegragene autotemcel)
    • For the treatment of pediatric patients with severe leukocyte adhesion deficiency type 1 (LAD-1).
  • Awiqli (insulin icodec-abae)
    • As an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes.
  • Neffy (epinephrine nasal spray)
    • Indication expanded to remove the age criteria so all children and adults who weigh 33 lbs. or more can utilize neffy for the emergency treatment of Type 1 allergic reactions, including anaphylaxis.

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