RxNews®

December 18, 2025 - Boehringer Ingelheim announced the FDA approval of Jascayd (nerandomilast), for the treatment of progressive pulmonary fibrosis (PPF) in adult patients.

December 9, 2025 - The FDA approved Merck’s Recarbrio (imipenem/ cilastatin/relebactam), in adult and pediatric patients weighing at least 2 kg for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible gram-negative microorganisms; Or who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections, including pyelonephritis, caused by the following susceptible gram-negative microorganisms. Or who have limited or no alternative treatment options for the treatment of complicated intra-abdominal infections caused by the following susceptible gram-negative microorganisms.

December 17, 2025 - The FDA announced the traditional (full) approval of pharmaand’s Rubraca (rucaparib), for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy.

December 18, 2025 - The FDA approved AbbVie’s Vraylar (cariprazine), for treatment of schizophrenia in adult and pediatric patients 13 years of age and older and for acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older.

December 16, 2025 - GSK announced the FDA approval of Exdensur (depemokimab), for the add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.

December 19, 2025 - Grifols announced the FDA approval of Fesilty (fibrinogen, human - chmt), for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.

December 21, 2025 - Roche announced the FDA approval of Lunsumio (mosunetuzumab-axgb), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

December 19, 2025 -  Cytokinetics announced the FDA approval of Myqorzo (aficamten), for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

December 17, 2025, the FDA announced the approval of J&J’s Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) subcutaneous injection, for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant®).

December 22, 2025 - Novo Nordisk announced the FDA approval of Wegovy (semaglutide) tablets, in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular (CV) events (MACE) (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight and to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition.

December 16, 2025 - MediNatura New Mexico announced a voluntary, consumer-level recall of all lots of ReBoost Nasal Spray because the product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications.

December 18, 2025 - The FDA announced that they have received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo).