10 recent drug, device approvals

Ten drugs or medical devices approved by the FDA since the end of December:

Editor's note: The approvals are listed chronologically, from most to least recent. 

  1. Memic Innovative Surgery's robotically assisted surgical device — A device that can help facilitate transvaginal hysterectomy procedures.

  2. Origin Biosciences' Nulibry — An injectable drug designed to reduce the risk of death from molybdenum cofactor deficiency type A, a rare, genetic, metabolic disorder that can cause intractable seizures, brain injury and death.

  3. Q30 Sports Science's Q-Collar — A device intended to be worn around the neck of athletes ages 13 years and older during sports to protect the brain from the effects of head impacts.

  4. Sarepta Therapeutics' Amondys 45 injection — A drug designed to treat Duchenne muscular dystrophy in patients with a specific gene mutation.

  5. Additive Orthopaedics' 3D-printed talus implant — A device designed to replace the talus, the bone in the ankle joint that connects the leg and foot. It's intended for treatment of avascular necrosis of the ankle joint, a condition that causes the death of bone tissue from a lack of blood supply to the area. 

  6. G1 Therapeutics' Cosela — A drug designed to reduce the frequency of chemotherapy-induced bone marrow suppression for adults with extensive-stage small cell lung cancer.

  7. Signifier Medical Technologies' sleep apnea device — A prescription-only device intended to reduce snoring and mild obstructive sleep apnea. It's the first device used while awake to improve tongue muscle function, which can help prevent the tongue from collapsing backward and obstructing the airway during sleep.

  8. ViiV Healthcare's Cabenuva —  A long-acting two-shot combination that helps HIV patients treat their condition more conveniently and privately. It's the first monthly injectable approved to treat HIV.

  9. Merck & Bayer's Verquvo — A drug designed to treat chronic heart failure, specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics.

  10. Amphastar Pharmaceuticals' glucagon generic — Glucagon has been approved in the U.S. for more than 20 years, but there were previously no generic versions of the drug, which is used to treat severe hypoglycemia.

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