Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...
Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed ...
The third quarter of 2025 closed amid growing macroeconomic strain, policy unpredictability and renewed investor focus on execution risk. While ...
This announcement summarizes Bioretec Ltd's business review for January–September 2025. The complete business review is attached to ...
Good morning, and welcome to the PAVmed's Third Quarter 2025 Business Update Conference Call. [Operator Instructions] This call is being recorded on Thursday, November 13, 2025. I would now like to ...
Clinical Trials Arena on MSN
FDA unveils new pathway to usher bespoke therapies to market
The “plausible mechanism pathway” will allow personalised drugs to reach the market sooner for patients with genetic diseases ...
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