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.
- 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.
- 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.
- 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.
- Supernus Pharmaceuticals' Qelbree — The first new drug designed to treat ADHD in children in over a decade.
- Medtronic's Harmony Transcatheter Pulmonary Valve System — The world's first nonsurgical heart valve device meant to treat patients with severe pulmonary valve regurgitation.
- 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.
- 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.
- 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.
- BioFire Diagnostics' COVID-19 test — The first COVID-19 test to receive full FDA approval.
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