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.
FDA misses its 4/1 user fee review action target date on a Novavax BLA seeking full approval for its current Covid-19 vaccine.
FDA says it is reprioritizing planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff we...
FDA clears a Medivis 510(k) for its Spine Navigation platform that uses augmented reality and artificial intelligence (AI) to assist surgeons in spina...
