Despite the uncertain macro environment created by the threat of reciprocal tariffs on goods into the U.S., some investors are still upbeat about the med tech sector. Even with changes at the HHS and disruption to product approvals throughout the FDA, venture capital investors remain cautiously optimistic. Read More
The U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard. Read More
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said. Read More
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd. Read More
The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytel, Dignitana, DNV, Icotec, Mediso, Nested Knowledge, Osteotec, Paxman, Superconducting Systems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb. Read More
