AbbVie is seeking a new way to fight chronic lymphocytic leukemia by combining its oncology drug Venclexta with another ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include ...

After a decade of development, a Kansas City-based pharmaceutical company is on the brink of submitting its ADHD medication ...

Biotech First-ever drug application for MDMA finally reaches FDA after near 40-year journey By Max Bayer Dec 13, 2023 9:39am MDMA New Drug Application psychedelic drug Food and Drug Administration ...

Johnson & Johnson (NYSE:JNJ) is one of the best trade‑war resistant stocks to buy now. On July 21, 2025, J&J submitted a New ...

Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review its resubmitted New Drug Application (NDA) for its lead drug reproxalap, ...

Alphamab Oncology ( (HK:9966) ) has shared an update. Alphamab Oncology announced that its Investigational New Drug application for JSKN022, a novel bispecific antibody-drug conjugate targeting PD-L1 ...

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

With a supplemental new drug application, a pharmaceutical company seeks to make changes to drug labels after they have been approved for other indications, for example, according to the FDA’s website ...

U.S. FDA Accepts New Drug Application for Merck’s DOR/ISL Once-Daily Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1.

Phase 2b and phase 3 trials may begin in 2025 and 2026, respectively. A new drug application is anticipated for 2029.

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 ...