RxNews®

September 2, 2025 - Henlius and Organon announced the FDA approval of Bildyos (denosumab-nxxp), biosimilar to Amgen’s Prolia® (denosumab).

September 2, 2025 - Henlius and Organon announced the FDA approval of Bilprevda (denosumab-nxxp), biosimilar to Amgen’s Xgeva® (denosumab). 

August 28, 2025 - The FDA approved Foresee Pharmaceuticals’ Camcevi ETM (leuprolide), for the treatment of adult patients with advanced prostate cancer.

August 27, 2025 - Pfizer and BioNTech announced the FDA approval of Comirnaty (COVID-19 vaccine, mRNA), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals who are 65 years of age and older, or 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

August 29, 2025 - Eisai and Biogen announced the FDA approval of Leqembi Iqlik™ (lecanemab-irmb), for the treatment of Alzheimer’s disease.

August 27, 2025 - Moderna announced the FDA approval of mNEXSPIKE (COVID-19 vaccine, mRNA), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

August 27, 2025 - Novavax announced the FDA approval of Nuvaxovid (COVID-19 vaccine, adjuvanted), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

August 27, 2025 - Moderna announced the FDA approval of Spikevax (COVID-19 vaccine, mRNA), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals who are 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

August 29, 2025 - Sanofi announced the FDA approval of Wayrilz (rilzabrutinib), for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

August 27, 2025 - Unichem announced a voluntary, consumer level recall of one lot of cyclobenzaprine tablets because the cyclobenzaprine 10 mg label was inadvertently placed on a bottle containing meloxicam 7.5 mg tablets.