Oyster Point announced that its nasal spray will become available next month for patients with a prescription, making it the first FDA-approved nasal spray in the US for chronic dry eye disease. The drug is aimed at filling the unmet medical need for people who suffer...
Johnson & Johnson (J&J) has submitted its data to the US FDA (Food and Drug Administration) for emergency use authorization for its booster shot of the J&J COVID-19 vaccination. The submission is based on the Phase 3 ENSEMBLE 2 study that shows that a...
The US FDA (Food and Drug Administration) has approved the first-ever chimeric antigen receptor (CAR) T-cell therapy, brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company) for adults with relapsed or refractory acute lymphoblastic leukemia (ALL). The approval...
The US FDA (Food and Drug Administration) announced that it has released a draft guidance for sponsors using an electronic template for premarket notification 510(k) submissions. According to the drafted guidance, the FDA explained that it plans to accept the...
Global leader in medical technology, Medtronic, has been granted CE Mark approval for its radial artery access portfolio, comprising of their Rist 079 Radial Access Guide Catheter and Rist Radial Access Selective Catheter. Characterized by its ability to access the...
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