Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's drug ...

"I may have been swayed if this represented a major advance in the field," said panelist Walter Dunn, MD, PhD, of the ...

An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been ...

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

The U.S. Food and Drug Administration's reviewers have raised efficacy concerns over Otsuka Pharma's combination drug for ...

Otsuka Pharma (OTCPK:OTSKY) and H. Lundbeck (OTCPK:HLBBF) draws efficacy concerns for their PTSD therapy from the FDA ahead ...

Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and ...

Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...

A new study by a Tulane University researcher casts doubt on a widely used shortcut in rectal cancer drug trials, raising ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...