Dimerix Limited (ASX:DXB) Secures Major Licensing Deal in Japan and FDA Endorsement for DMX-200
Dimerix Limited (ASX:DXB) secures a ¥10.5 billion licensing deal in Japan and receives FDA endorsement for its DMX-200 therapy.
Tag: Regulatory News & Compliance
EMVision Medical Devices Limited (ASX:EMV) Launches Clinical Trial for emu™ Device
EMVision Medical Devices Limited (ASX:EMV) has commenced pivotal clinical trials for its emu™ brain scanner and announced successful device testing and robust cash reserves.
Bubs Australia Limited (ASX:BUB) Wins Arbitration Awards
Bubs Australia Limited (ASX:BUB) secures $22.9M and $3.6M arbitration awards against Alpha Group subsidiaries.
Health and Plant Protein Group Limited (ASX:HPP) Releases FY25 Q3 Activities Report
Health and Plant Protein Group Limited (ASX:HPP) releases FY25 Q3 report, highlighting cash flow and ongoing IRS repayment efforts.
Orthocell Limited (ASX:OCC) Gains Thai FDA Approval for Remplir™
Orthocell (ASX:OCC) receives Thai FDA approval to launch Remplir™, expanding into the US$84 million nerve repair market.
Evion Group NL (ASX:EVG) Secures Community Support and Advances Maniry Graphite Mine
Evion Group NL (ASX:EVG) secures community support for the Maniry Graphite Mine and advances toward final environmental approvals.
Lumos Diagnostics (ASX:LDX) Secures Additional Medicare Coverage
Lumos Diagnostics (ASX:LDX) expands Medicare reimbursement for FebriDx to over 55% of US coverage, enhancing market access.
Imricor Medical Systems (ASX:IMR) Receives CE Mark Approval for Advantage-MR System
Imricor Medical Systems (ASX:IMR) secures CE Mark approval for its Advantage-MR system under the new EU Medical Device Regulation, anticipating EU launch in June.
CZR Resources Ltd (ASX:CZR) Announces Trading Halt
CZR Resources Ltd (ASX:CZR) announces a trading halt pending an update on the Robe River Joint Venture offer.
PainChek Ltd (ASX:PCK) Secures $1.41M R&D Tax Refund, Advances FDA Review, and Launches Infant App
PainChek Ltd (ASX:PCK) secures a $1.41m R&D tax refund, advances FDA review for its Adult App, and launches the Infant App on Apple App Store.