It’s been more than three years since DBV Technologies’ peanuty allergy therapy was rejected for FDA approval, but the company thinks it now has a clear route to market with its patch product ...

An FDA-approved biosimilar is a biological product that is highly similar to and has no clinically meaningful differences in terms of safety or effectiveness from an existing FDA-licensed ...

The "FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control" has been added to ResearchAndMarkets.com's offering. Join our upcoming webinar to delve into the intricate FDA ...

The Food and Drug Administration launched an “aggressive timeline” on Thursday that charts its internal efforts ... in aiding scientific reviews, FDA Commissioner Martin Makary announced ...

The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...

Real-time index price for S&P 500 Index (INX), along with buy or sell indicators, analysis, charts, historical performance, ...

The US Food and Drug Administration (FDA) has outlined two suitable primary endpoints based on proteinuria (excess protein in urine) levels for DXB’s Phase 3 ACTION3 trial, including either a ...

The FDA said Tuesday that the review -- part of its "Operation Stork Speed" initiative -- will look at whether current nutrient requirements need to be updated, including whether additional ...

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...