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AbbVie is seeking a new way to fight chronic lymphocytic leukemia by combining its oncology drug Venclexta with another ...
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 ...
Shares of Zymeworks were higher after the Food and Drug Administration cleared the company's investigational new drug application for its treatment for liver cancer. The stock rose 8.5%, to $14.46, in ...
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, ...
The FDA accepted a resubmitted new drug application for reproxalap, a first-in-class investigational topical therapy for dry ...
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.
Provided by PR Newswire May 22, 2025, 7:44:00 PM FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418 ...
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 ...
The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...
Connect Biopharma's collaborator, Simcere, has submitted a New Drug Application for rademikibart in China, marking a significant step towards potential commercialization in a large market.
The application has been assigned a real-time oncology review, which allows for a more efficient review and engagement between Syndax and the FDA, the New York biopharmaceutical company said Tuesday.