Finland, Sweden & Denmark Limit Moderna COVID-19 Vaccine
Following the release of a Nordic study, Finland joins Sweden and Denmark in pausing the distribution of the Moderna COVID-19 vaccine for young adult males (under 30) after reports of a rare cardiovascular side effect. The unpublished study will be sent to the...
J&J Submits Booster Emergency Use Authorization to FDA
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...
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FDA Releases Electronic 510(k) Submissions Draft Guidance
The US FDA (Food and Drug Administration) announced that it has released a draft guidance for sponsors using an electronic template for premarket notification 510(k) submissions.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...