From a Becker’s Hospital Review (BHR) online release article:
10 drugs and medical devices approved by the FDA since Dec. 6:
- Enhertu is Japanese drugmaker Daiichi Sankyo’s drug designed to treat HER2-positive breast cancer.
- Padcev is Astellas Pharma’s drug designed to target specific cancer cells to treat urothelial cancers.
- Control-IQ Technology controller is Tandem Diabetes Care’s insulin device, designed to help diabetes patients tailor their treatments to their individual needs.
- Vascepa is Amarin Pharmaceuticals’ drug, a fish oil-derived pill designed to treat cardiovascular events.
- EXALT Model D is Boston Scientific’s device, the first fully disposable duodenoscope, designed to reduce the risk of infections in patients treated with the device.
- Vyondys 53 is Sarepta Therapeutics’ drug designed to treat Duchenne muscular dystrophy, which the FDA had previously rejected.
- GSP Neonatal Creatine Kinase-MM kit is PerkinElmer’s device, used to detect Duchenne Muscular Dystrophy in newborns.
- Unidose liquid system is AptarGroup’s device that uses a nasal spray to treat seizures. It is the first and only nasal treatment for patients with epilepsy.
- Avsola is Amgen’s drug, a biosimilar of Johnson & Johnson’s Remicade. It is designed to treat rheumatoid arthritis, Crohn’s disease, plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
- cobas vivoDx is Roche Molecular Systems’ device, designed to diagnose MRSA hours faster than traditional tests.