Acute Lymphoblastic Leukemia (ALL): First Approved CAR T-Cell
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...
Merck COVID-19 Pill Gives Hope in Preventing COVID-19 Deaths
Experimental antiviral COVID-19 treatment pill, molnupiravir, developed by Merck & Co Inc and partner Ridgeback Biotherapeutics LP, presents promising results in halving the chances of dying or being hospitalized from COVID-19. If authorized, the pill would be the...
Diabetes: 20+ Year Study Shows Abnormal Nighttime BP Risky
Longitudinal study funded by the University of Pisa. Chiriacò and McLaughlin shows that adults with diabetes who experience abnormal blood pressure (PB) patterns overnight which either do not drop as expected (nondipping) or, increase at night (reverse dipping) are at...
FDA Releases Electronic 510(k) Submissions Draft Guidance
The US FDA (Food and Drug Administration) announced that it has released a draft guidance for sponsors using an electronic template for premarket notification 510(k) submissions.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...
CE Mark Approval for Medtronic Radial Artery Portfolio
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...
GSK’s COVID-19 Antibody Treatment Approved in Japan
GSK's (GlaxoSmithKline) and Vir Biotechnology's antibody treatment for COVID-19, Sotrovimab has been approved in Japan, Health Minister Norihisa Tamura announced this week. Aiming to treat mild to moderate coronavirus cases, GSK's antibody treatment does not require...
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