RxNews®

December 15, 2025 - Sprout Pharmaceuticals announced the FDA approval of Addyi (flibanserin), for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.

December 12, 2025 - J&J announced the FDA approval of Akeega (niraparib/abiraterone), with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC).

December 11, 2025 - GSK announced the FDA approval of Blujepa (gepotidacin), in adult and pediatric patients 12 years of age and older weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae.

December 16, 2025 - The FDA announced the approval of AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki), in combination with pertuzumab, for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

December 8, 2025- The FDA announced the approval of Gamida Cell’s Omisirge (omidubicel-onlv), for the treatment of adults and pediatric patients 6 years of age and older with severe aplastic anemia (SAA) following reduced intensity conditioning.

December 12, 2025 - BioCryst announced the FDA approval of Orladeyo (berotralstat), for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older.

December 11, 2025 - Amgen announced the FDA approval of Uplizna (inebilizumab-cdon), for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. 

December 12, 2025 - Milestone Pharmaceuticals announced the FDA approval of Cardamyst (etripamil), for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

December 12, 2025 - Acadia Pharmaceuticals announced the FDA approval of Daybue Stix (trofinetide) powder for oral solution, for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

December 15, 2025 - LIB Therapeutics announced the FDA approval of Lerochol (lerodalcibep-liga), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

December 12, 2025 - Innoviva announced the FDA approval of Nuzolvence (zoliflodacin), for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.

December 9, 2025 - The FDA announced the approval of Fondazione Telethon’s Waskyra (etuvetidigene autotemcel), for the treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.

December 10, 2025 - MediNatura New Mexico announced a voluntary, consumer-level recall of one lot of ReBoost Nasal Spray because the product contains yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications.