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Orthocell Secures Landmark US FDA Clearance for Remplir™, Unlocking US Market
Orthocell (ASX: OCC) has received US FDA 510(k) clearance for its nerve repair product, Remplir™, opening access to the US$1.6 billion US...
4 days ago


Argent's CannEpil™ Wins Approval for German Prescription Under Special Access Scheme
Argent BioPharma (ASX: RGT) has secured approval for its cannabinoid-based epilepsy treatment, CannEpil™, to be prescribed in Germany....
5 days ago


Race Oncology Opens First Australian Clinical Site for RC220 Phase 1 Trial
Race Oncology (ASX: RAC) has announced the activation of the first Australian clinical site for its Phase 1 trial of RC220, an innovative...
5 days ago


Mesoblast Receives Medicaid Coverage for Ryoncil, First Patients Begin Treatment
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) has secured U.S. Medicaid coverage for its FDA-approved mesenchymal stromal cell (MSC) therapy,...
Mar 31


Echo IQ Expands AI-Powered Heart Tech Across 36 US Hospitals
Sydney-based Echo IQ (ASX: EIQ) has secured integration agreements with ScImage and MedAxiom, bringing its AI-driven EchoSolv AS...
Mar 31


Avecho Secures US$3M Upfront Payment from Sandoz in CBD Licensing Deal
Avecho Biotechnology (ASX: AVE) has secured a US$3 million upfront payment from Sandoz AG for exclusive rights to market its Phase III...
Mar 27


Mesoblast's Ryoncil Hits U.S. Market as First FDA-Approved MSC Therapy
Mesoblast (ASX:MSB), announced that its flagship therapy, Ryoncil® (remestemcel-L), is now available for purchase in the United States....
Mar 27


Neuren Targets Breakthrough Treatment for Newborn Brain Injury with NNZ-2591
Neuren Pharmaceuticals (ASX: NEU) is expanding its pipeline with a new initiative: developing NNZ-2591 to treat (HIE), a severe brain...
Mar 27


Opthea’s Wet AMD Drug Fails Phase 3 Endpoints; in Discussion with Creditors
Opthea Ltd. (ASX/NASDAQ: OPT) announced that its COAST Phase 3 trial for wet age-related macular degeneration (wet AMD) failed to meet...
Mar 26


LTR Locks in FDA Pathway, Fast-Tracks U.S. Expansion with Roxus®
LTR Pharma (ASX: LTP) has hit a major regulatory milestone with the U.S. FDA while ramping up its commercial push in the U.S. and...
Mar 25


Immutep Doses First Patient in Pivotal Phase III Lung Cancer Trial
Immutep (ASX: IMM; NASDAQ: IMMP) has taken a major step forward in its pursuit of a groundbreaking lung cancer treatment, dosing the...
Mar 25


Beamtree Wins $4M Contract to Deliver PICQ Software to Ireland
Beamtree Holdings (ASX: BMT) has won a five-year contract renewal worth AU$3.95 million (€2.3 million) to provide its market-leading...
Mar 21


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