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 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 eyes FDA nod to icotrokinra after phase III studies show strong skin clearance and safety in plaque ...

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 ...

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 ...

FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418. PR Newswire. SHANGHAI and SAN DIEGO, May 22, 2025.

NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with ...

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.