A new drug-releasing system, TAR-200, eliminated tumors in 82% of patients in a phase 2 clinical trial for individuals with ...

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a ...

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the ...

The FDA has agreed to fast-track its review of gepotidacin, an oral antibiotic already approved for urinary tract infections, ...

An update from Shanghai Henlius Biotech, Inc. Class H ( ($HK:2696) ) is now available. Shanghai Henlius Biotech, Inc. announced that its New Drug ...

A new FDA program will use a two-phase approach to help boost domestic drug manufacturing, while OpenAI is leaning into health care with the launch of GPT-5.

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 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.

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.

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 ...

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.