MESQUITE, NV, Oct. 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process ...

The Food and Drug Administration (FDA) has issued another Complete Response Letter (CRL) to Regeneron (CRL) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory ...

After submission of an initial Investigational New Drug Application (IND), the FDA requested additional studies and information as a prerequisite for approval of PharmaCyte’s IND.

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license application for vusolimogene oderparepvec in combination with nivolumab for the ...

LONDON (MarketWatch) -- GPC Biotech [:de:585150] on Monday said the U.S. Food and Drug Administration has accepted for filing the company's new drug application for Satraplatin in combination with ...