News

FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval ...
BioSpace4d
FDA Mulls ‘Regulatory Action’ on Argenx’s Vyvgart Hytrulo Over Severe Safety Concerns
The safety update for Vyvgart rattled argenx’s shares on Monday, a reaction that analysts at William Blair said was “overdone ...
MassDevice5d
Onward submits ARC-EX to FDA for home use, seeks CE mark too
Onward Medical announced today that it submitted its ARC-EX system for expanded FDA indication and for CE mark approval.
MassDevice6d
Olympus to address FDA concerns over Japan manufacturing that led to import alerts
Olympus announced recently that it is committed to addressing the concerns of the FDA around its device manufacturing in ...
MedTech Dive6d
Olympus pledges prompt response following FDA import block
Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...
STAT6d
Many medical devices deemed ‘breakthrough’ by FDA are backed by patchy evidence
The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.
Healthcare Dive6d
FDA stops Olympus devices from entering the US
The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...