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...
FDA warns Columbus, OH-based Rex Implants that it is illegally manufacturing and distributing three medical devices.
