Berlin: Bayer has announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug ...

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 ...

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

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

The Trump administration’s proposed cuts at the National Institutes of Health and Food and Drug Administration could lower ...

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

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

First-ever drug application for MDMA finally reaches FDA after near 40-year journey By Max Bayer Dec 13, 2023 9:39am ...

A new drug application submitted to the FDA seeks approval of roflumilast foam 0.3% for adults and adolescents with moderate to severe seborrheic dermatitis, Arcutis Biotherapeutics announced in a ...

U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 Infection.