Mesoblast (ASX:MSB), announced that its flagship therapy, Ryoncil® (remestemcel-L), is now available for purchase in the United States....

Neuren Pharmaceuticals (ASX: NEU) is expanding its pipeline with a new initiative: developing NNZ-2591 to treat (HIE), a severe brain...

Opthea Ltd. (ASX/NASDAQ: OPT) announced that its COAST Phase 3 trial for wet age-related macular degeneration (wet AMD) failed to meet...

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...

Immutep (ASX: IMM; NASDAQ: IMMP) has taken a major step forward in its pursuit of a groundbreaking lung cancer treatment, dosing the...

Beamtree Holdings (ASX: BMT) has won a five-year contract renewal worth AU$3.95 million (€2.3 million) to provide its market-leading...

Telix Pharmaceuticals (ASX: TLX) has received FDA approval for Gozellix®  (TLX007-CDx), its next-generation prostate-specific membrane...

Imricor Medical Systems (ASX: IMR) has taken a A$70 million (US$44 million) capital raise, taking Imricor’s cash reserves to A$87.3...

Nanosonics (ASX: NAN), a hospital infection prevention company, has secured a key regulatory milestone, with the FDA granting De Novo...

Neurizon Therapeutics (ASX: NUZ) has formally requested guidance from the FDA, seeking to understand what specific new pharmacokinetic...

Australian biotech company Imugene (ASX:IMU) has received a regulatory boost, with the FDA granting Fast Track Designation to its...

EMVision Medical Devices (ASX: EMV) has successfully completed aeromedical testing of its First Responder Proof-of-Concept (PoC) device -...