Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...

The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...

The FDA has approved expanded use of GE HealthCare’s PET imaging agent, Vizamyl, for improved detection and monitoring of Alzheimer’s disease. The updated label now allows Vizamyl to be used to detect ...

Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final ...

The drug compounder Hybrid Pharma LLC, an FDA outsourcing facility, lost its Eleventh Circuit attempt to revive a lawsuit ...

Cue Biopharma has received positive feedback from the Food and Drug Administration for its first in-human trial design for CUE-401, a protein that aims to treat autoimmune disease. The ...

New study results position Nuvalent to bring forward what it claims is a differentiated treatment for ROS1-positive lung ...

She wrote that she decided to leave the agency after taking a recent vacation, and thanked staff for their “unwavering support, especially during recent challenging times.” Corrigan-Curay will remain ...

Brain metastases are common in ROS1-positive NSCLC, particularly after disease progression. Among 56% with measurable brain ...

Pfizer jumps into cancer-treatment race with a $6 billion licensing deal with a China-based company, six months after Merck’s move for a lot less money.

Peer Reviewed: Isotopically Labeled Analogues for Drug Quantitation. Issues to address when isotopically labeled analogues of analytes are used as internal standards. Ray H. Liu, D.-L. Lin, Wei-Tung ...