GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

The FDA accepted a resubmitted new drug application for reproxalap, a first-in-class investigational topical therapy for dry ...

The US Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

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

SHELTON, CT / ACCESS Newswire / July 21, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.: NNVC ) (the ...

David Koos, the Chairman and CEO of Regen Biopharma, Inc., discussed the Company’s intention to seek Orphan Drug Designation for HemaXellerate, the Company’s proprietary aplastic anemia cell therapy ...

The submission is supported by four Phase III clinical trials, which showed that icotrokinra demonstrated significant skin ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

Aldeyra plans to resubmit the new drug application later this year, pending positive results. Nearly 5 months after the FDA did not approve reproxalap for dry eye, ...