RxNews®

February 12, 2026 - The FDA approved Novartis’ Leqvio (inclisiran), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemial; Adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia; or Pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia.

February 17, 2026 - Harmony Biosciences announced the FDA approval of Wakix (pitolisant), for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.

February 12, 2026 - The FDA approved Acrotech Biopharma’s Adquey (difamilast), for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.

February 13, 2026 - The FDA approved Avyxa Pharma’s Avopef (etoposide) injection, in combination with chemotherapy for the treatment of refractory testicular cancer in adult patients and in combination with chemotherapy and immunotherapy for the first-line treatment of small cell lung cancer (SCLC) in adult patients.

February 20, 2026 - Vanda Pharmaceuticals announced the FDA approval of Bysanti (milsaperidone), for the treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.