Browsing: FDA

Biosplice submits NDA for lorecivivint, a potential first-of-its-kind therapy that aims to slow knee osteoarthritis itself. Osteoarthritis shapes how millions…

Loyal’s lead drug for senior dogs moves closer to market, marking a rare regulatory milestone for lifespan extension. The gray…

Nephrodite’s device designed to ‘free patients from the cycle of center-based dialysis’ becomes the first to receive the designation.  …

The approval marks a milestone for GLP-1 drugs, expanding access beyond injections as Novo Nordisk prepares for a competitive obesity…

FDA clears ENV-308 for Phase 1 as Enveda doses first patient and appoints former Novo Nordisk executive to lead metabolic…

Safety review, political shifts and fading demand challenge Moderna as mRNA medicine pushes into broader therapeutic territory. The US Food…

Credit: JDawnInk / Getty Images / DigitalVision Vectors A new analysis from researchers at UC Riverside and UC Irvine found…

AstraZeneca’s potential first-in-class aldosterone inhibitor could help millions with hard-to-control high blood pressure. Global biopharmaceutical company AstraZeneca announced that the…

FDA greenlights early-stage trial of VectorY’s first-in-class therapy targeting the core biology driving most ALS cases. Netherlands-based biotech VectorY Therapeutics…

Voyxact gets accelerated approval, offering investors a new entrant in the high-value kidney disease market. The Food and Drug Administration…