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

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug Administration based on data evaluating the efficacy of its oral drug ...

Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease November 29, 2022 08:00 AM ...

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

The application is supported by data from 2 randomized, open-label, multicenter phase 3 clinical studies (NCT04292730 and NCT04292899) conducted by Gilead and a randomized, placebo-controlled ...

Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 ...

Press Release Circle Pharma, a leader in macrocycle drug discovery and development, announced the submission of its first Investigational New Drug (IND) application to the U.S. Food and Drug ...

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.