BeiGene scraps the development of BGB-A1217 (ociperlimab), an anti-TIGIT antibody, as a potential treatment for lung cancer.
FDAs accelerated approval program faces renewed scrutiny after a recent JAMA study highlighted concerns about cancer drugs that remain available despi...
Biogen wins a fast-track designation for BIIB080, an investigational antisense oligonucleotide therapy for treating Alzheimers disease.
Former FDA commissioner Mark McClellan says it will be a challenge for the agency to come through the massive reorganization and staff reduction that ...
Industry associations sound alarms and frustrations as they weigh how FDA staff cuts will impact product development, FDA reviews and approvals.
Roche says the Phase 3 MUSETTE study found that a higher dose of Ocrevus IV did not provide more benefit than the approved 600 mg dose in treating rel...
Edgewise Therapeutics says its EDG-7500 achieved positive results in the four-week CIRRUS-HCM trial in hypertrophic cardiomyopathy.
The Senate HELP Committee invites HHS secretary RFK, Jr., to testify on his reorganization of the department.