Browsing: FDA

Robert F. Kennedy, Jr. opens the HHS briefing in Washington DC to unveil the agency’s draft guidance for rare disease…

Moderna researchers at work in the company’s lab. The FDA’s reversal of its earlier refusal to review mRNA-1010, the seasonal…

Funding to support commercial launch and continued development of treatments designed to ‘rejuvenate vision in the aging eye.’ British-American biotech…

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…