GRAIL is the only company that has applied for MCED FDA premarket approval so far; if approved by the FDA and covered by ...

Casgevy also now indicated for transfusion-dependent beta thalassemia in children 2 years ...

FDA authorized Tregzi for adults with acute leukemia, MDS, and other hematologic malignancies receiving closely matched donor ...

Given the impact that bad sunscreen can have on people's health, it's important that new sunscreen ingredients are seriously tested for their safety. A 2020 study by FDA researchers demonstrated that ...

July 1 (Reuters) - The U.S. Food and Drug Administration approved expanded use of Vertex Pharmaceuticals' gene therapy in ...

The U.S. Food and Drug Administration has granted accelerated approval to Sanofi's Tzield (teplizumab-mzwv) to delay the ...

Orca-T integrates HSPCs for reconstitution, highly purified Tregs for GVHD suppression, and Tcons to accelerate immune recovery and preserve graft-versus-leukemia activity via a matched-donor, patient ...

A sunscreen ingredient that's been available in Europe, Japan and South Korea for years has finally been approved by the FDA ...

FDA approved veligrotug-vvze for TED regardless of activity or duration, using a 12-week course of five IV infusions administered every three weeks. Pivotal THRIVE/THRIVE-2 trials met primary and all ...

In February, the FDA issued an Emergency Use Authorization for Ivomec injectable solution against New World screwworm.

The announcement comes months after UniQure became embroiled in a public debate with FDA leaders over the clinical trial data ...

Move follows actions "inconsistent with proper research conduct," journal says ...