A consolidated list of all the FDA approved medications during the month of February 2026.

  • Sogroya (somapacitan-beco) New Indication 
    • For children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS).
  • Yuviwell (navepegritide)
    • To increase linear growth in children 2 years and older with achondroplasia with open epiphyses.
  • Hernexeos (zongertinib) New Indication 
    • 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.
  • Desmoda (desmopressin acetate) 
    • For the management of central diabetes insipidus, as antidiuretic replacement therapy for patients of all ages.
  • Dupixent (dupilumab) New Indication 
    • For the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.
  • Loargys (pegzilarginase-nbln) 
    • For the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction.
  • Bysanti (milsaperidone) 
    • For the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.
  • Calquence (acalabrutinib + venetoclax) New Indication 
    • In combination with venetoclax for the first-line treatment of adults with chronic lymphocytic leukemia (CLL), including small lymphocytic lymphoma.
  • Enzeevu (aflibercept-abzv) Expanded Indication 
    • Expanded to include patients with macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR) and diabetic macular edema (DME).
  • Wakix (pitolisant) Expanded Indication 
    • For the treatment of cataplexy in patients 6 years of age and older with narcolepsy.
  • Adquey (difamilast)  
    • For the treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.
  • Optune Pax 
    • For treatment of patients with locally advanced pancreatic cancer, in combination with gemcitabine and nab-paclitaxel.
  • Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Expanded Indication 
    • 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.
  • Keytruda (pembrolizumab) Expanded Indication
    • 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.
  • Yescarta (axicabtagene ciloleucel) Expanded Indication
    • Updated indication, removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).
  • Vybrique (sildenafil)  
    • To treat men aged 18 years and older with erectile dysfunction.

Make sure to sign up for alerts and stay informed on all the latest published guidelines, FDA decisions, and more!

Copyright © 2026 Guideline Central, All Rights Reserved.