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

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

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

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

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

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.

FDA approves Longeveron's stem cell therapy for rare pediatric heart condition, advancing to Phase 2 trial. Treatment aims to repair damaged tissue.

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 ...

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 ...