10 recent drug, device approvals

10 drugs and medical devices approved by the FDA since Dec. 6:

  1. Enhertu is Japanese drugmaker Daiichi Sankyo's drug designed to treat HER2-positive breast cancer.

  2. Padcev is Astellas Pharma's drug designed to target specific cancer cells to treat urothelial cancers.

  3. Control-IQ Technology controller is Tandem Diabetes Care's insulin device, designed to help diabetes patients tailor their treatments to their individual needs.

  4. Vascepa is Amarin Pharmaceuticals' drug, a fish oil-derived pill designed to treat cardiovascular events.

  5. 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.

  6. Vyondys 53 is Sarepta Therapeutics' drug designed to treat Duchenne muscular dystrophy, which the FDA had previously rejected.

  7. GSP Neonatal Creatine Kinase-MM kit is PerkinElmer's device, used to detect Duchenne Muscular Dystrophy in newborns.

  8. 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.

  9. 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.

  10. cobas vivoDx is Roche Molecular Systems' device, designed to diagnose MRSA hours faster than traditional tests. 

More articles on pharmacy:
Drugmakers shift from clinical trials, mine EMRs for drug approvals
Momenta settles drug monopoly lawsuit with Nashville hospital for $35M
Merck scores 1st U.S.-approved Ebola vaccine

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