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

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 ...

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

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

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

Munich news, health insurance, technology, jobs and other topics for expatriates. The Eye Newspapers covers daily news and offers services for foreigners.

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

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

FDA reviewers flag "discordant results" in a briefing document published ahead of Friday's advisory committee meeting for the ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.