LTR Pharma Limited (ASX:LTP) Advances Multi-Market Strategy with FDA Milestone and Roxus Launch
LTR Pharma (ASX:LTP) achieves FDA approval path for SPONTAN and launches Roxus to accelerate US market entry.
Tag: Regulatory News & Compliance
Vulcan Energy (ASX:VUL) Awarded EU Strategic Project Status under Critical Raw Materials Act
Vulcan Energy (ASX:VUL) is recognised as an EU Strategic Project under the Critical Raw Materials Act, advancing sustainable lithium supply in Europe.
EBR Systems (ASX:EBR) Advances Leadless Pacemaker Technology with Successful Trials
EBR Systems (ASX:EBR) reports successful SOLVE-CRT trials and outlines a clear FDA approval pathway for its innovative leadless pacemaker system.
Berkeley Energy Limited (ASX:BKY) Addresses Share Price and Trading Volume Surge
Berkeley Energy Limited (ASX:BKY) addresses increased share price and trading volume, detailing compliance and key developments in Spain’s nuclear sector.
I Synergy Group Limited (ASX:IS3) Requests Trading Halt for Capital Raising
I Synergy Group Limited (ASX:IS3) requests a trading halt to complete a proposed capital raising, expected to resume by 27 March 2025.
Telix Pharmaceuticals Limited (ASX:TLX) Receives FDA Approval for Gozellix®
Telix Pharmaceuticals (ASX:TLX) announces FDA approval for Gozellix®, expanding prostate cancer imaging access in the U.S.
WiseTech Global Limited (ASX:WTC) Announces Board Review Update
WiseTech Global Limited (ASX:WTC) provides an update on the ongoing board review and governance measures amidst investigations involving Executive Chair Mr Richard White.
C29 Metals (ASX:C29) Expands Ulytau Project with New Exploration Licence
C29 Metals (ASX:C29) secures a new exploration licence, expanding the Ulytau Project footprint by 116 km² in Kazakhstan.
Imugene Limited (ASX:IMU) Granted FDA Fast Track Designation for Azer-cel
Imugene Limited (ASX:IMU) secures FDA Fast Track designation for its allogeneic CAR T-cell therapy azer-cel, advancing treatment for relapsed or refractory diffuse large B-cell lymphoma.
New Zealand King Salmon (ASX:NZK) Reports Increased Mortality Affecting FY26 Harvest
New Zealand King Salmon (ASX:NZK) faces higher sea farm mortality impacting FY26 harvest projections while maintaining FY25 financial guidance.