A consolidated list of all the FDA approved medications during the month of March 2026.
- Neffy (epinephrine nasal spray) Expanded Indication
- 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.
- Kresladi (marnetegragene autotemcel)
- For the treatment of pediatric patients with severe leukocyte adhesion deficiency type 1 (LAD-1).
- 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.
- 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.
- Opdivo (nivolumab) New Indication
- 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.
- Imcivree (setmelanotide) New Indication
- To treat acquired hypothalamic obesity (HO) in adults and pediatric patients aged 4 years and older.
- Lynavoy (linerixibat)
- For the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis.
- Wegovy HD (semaglutide)
- For weight loss and long-term maintenance of weight loss for certain adult patients.
- 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 who are candidates for systemic therapy or phototherapy.
- Cosentyx (secukinumab) Expanded Indication
- For patients 12 years and older with moderate to severe hidradenitis suppurativa (HS).
- Arexvy (respiratory syncytial virus vaccine, [adjuvanted])) Expanded Indication
- Expanded to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV.
- Wellcovorin (leucovorin) New Indication
- For 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.
- Pylarify TruVu (piflufolastat F 18) New Formulation
- 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.
- Sotyktu (deucravacitinib) New Indication
- For the treatment of adults with active psoriatic arthritis.
- Tecvayli + Darzalex Faspro (teclistamab-cqyv + daratumumab and hyaluronidase-fihj) New Combination
- 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.
- Juxtapid (lomitapide) Expanded Indication
- For the treatment of patients 2 years of age and older with homozygous familial hypercholesterolemia.
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