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

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

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

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

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

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

Many FDA accelerated approvals continue to rely heavily on surrogate endpoints, raising ongoing uncertainty about the true ...

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

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

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

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

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