- NDA assigned a Target Action Date of February 25, 2026 - ...

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug ...

The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, announced today that the China National Medical ...

FDA Commissioner Dr. Marty Makary is leading a handful of controversial new initiatives to make the drug review process more ...

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll children with high grade glioma and ependymoma HOUSTON, June 25, 2025 (GLOBE ...

Australians progressing the work of a Nobel prize-winning chemist have developed a superbug-­destroying protein using ...

Researchers at the University of Colorado Boulder have created a new way to build and control tiny particles that can move ...

Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...