Perspective from Lynda Mitchell, MA, CAE The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating anaphylaxis and other type 1 ...

A groundbreaking wireless implant promises real-time, personalized pain relief using AI and ultrasound power no batteries, no ...

Scientists have created tiny disk-shaped particles that can swim on their own when hit with light, akin to microscopic robots ...

Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll ...

Aldeyra had received 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.

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 ...

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

The FDA plans to approve selected high-priority drug application submissions in 1 to 2 months rather than 10 to 12.

The investigational MRI contrast agent, gadoquatrane, is designed to deliver effective imaging at a significantly reduced ...

Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items ...