cute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older

treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease

treatment of moderate to severe pain in adults, either by itself of with other nonsteroidal anti-inflammatory drug (NSAID) analgesics

to lower LDL cholesterol in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease

treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor

for adults with Cushing’s disease who either can’t have pituitary gland surgery or who have had the surgery but still have the disease

treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors

treatment of pediatric patients aged 2 years and older with type 1 neurofibromatosis (NF1) with symptomatic, inoperable plexiform neurofibromas

adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test

Advanced medullary thyroid cancer (MTC) or MTC that has spread, in patients 12 and older who require systemic therapy (a treatment option that spreads across the entire body, is not targeted) – AND – Advanced RET fusion-positive thyroid cancer in those age 12 and older that requires systemic therapy that has stopped responding to radioactive iodine therapy or is not appropriate for radioactive iodine therapy – AND – Non-small cell lung cancer (NSCLC) that has spread in adults.

treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate

positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD)

to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)

reatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above

treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression, after platinum-based chemotherapy

treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older

to treat intractable chronic low back pain associated with multifidus muscle dysfunction found on imaging or physiologic testing in adults who have failed other therapies and are not candidates for spine surgery

treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy

long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide

a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD)