The U.S. Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign ...

C-Path quickly emerged as a pioneer in accelerating drug development by launching landmark consortia and earning early regulatory endorsements for innovative safety kidney biomarkers by FDA ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

NCP is a condition that causes severe pain and sensitivity of the eyes, face, or head. The exact cause is unknown but is ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic ...

FDA conducts 12K domestic inspections ... executive order on Monday to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites ...

Kennedy Jr. and Food and Drug Administration Commissioner Marty Makary spelled out a regulatory path for removing the color additives ... (Getty Images) The FDA will take steps to eliminate the ...

Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...

In preparation for the new drug application (NDA ... Ironwood believed there was a regulatory path forward. Following a recent dialogue with the FDA, the company said a confirmatory Phase 3 ...