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

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

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

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 ...

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

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...

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

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

The US Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from ...

The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...