9 recent drug, device approvals

Nine drugs or medical devices approved by the FDA since mid-March:

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

  1. GlaxoSmithKline's Jemperli — A treatment for patients with recurrent or advanced endometrial cancer that has progressed during or following prior treatment with a specific type of chemotherapy, and for patients whose cancers have a specific genetic feature known as dMMR. 

  1. Bristol Myers Squibb's Opdivo — A treatment for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. It is approved in combination with certain types of chemotherapy and is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

  2. Cosmo Artificial Intelligence's GI Genius — The first device that uses artificial intelligence based on machine learning to assist clinicians in detecting lesions, such as polyps or suspected tumors, in the colon in real time during a colonoscopy.

  3. Supernus Pharmaceuticals' Qelbree — The first new drug designed to treat ADHD in children in over a decade.

  4. Medtronic's Harmony Transcatheter Pulmonary Valve System — The world's first nonsurgical heart valve device meant to treat patients with severe pulmonary valve regurgitation.

  5. Bristol Myers Squibb's Abecma — A cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after at least four different types of therapy.

  6. Helius Medical's Portable Neuromodulation Stimulator — A short-term treatment for gait deficit due to mild to moderate symptoms from multiple sclerosis. It is a neuromuscular tongue stimulator that generates electrical pulses for stimulation of facial nerves via the tongue to provide treatment for motor deficits.

  7. Astellas Pharma's Myrbetriq — The FDA approved a new indication for Myrbetriq to treat neurogenic detrusor overactivity, a  bladder dysfunction related to neurological impairment, in children ages 3 years and older. It's already approved to treat overactive bladder in adults.

  8. BioFire Diagnostics' COVID-19 test — The first COVID-19 test to receive full FDA approval. 

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US to share entire AstraZeneca COVID-19 vaccine supply with other nations

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