Orthocell Limited (ASX:OCC) Receives FDA Clearance for Remplir™
Orthocell (ASX:OCC) secures FDA clearance for Remplir™, enabling entry into the US $1.6 billion nerve repair market.
Tag: Regulatory News & Compliance
Echo IQ (ASX:EIQ) Partners with Mayo Clinic Platform, Advances EchoSolv HF towards FDA Clearance
Echo IQ (ASX:EIQ) partners with Mayo Clinic Platform to advance EchoSolv HF and progress towards FDA clearance for its heart failure solution.
Gold Mountain Limited (ASX:GMN) Announces Entitlement Offer and Director Appointment
Gold Mountain Limited (ASX:GMN) announces a $3.05m entitlement offer and appoints a new director to support its exploration initiatives.
Epsilon Healthcare Limited (ASX:EPN) Enters Voluntary Administration
Epsilon Healthcare Limited (ASX:EPN) enters voluntary administration, resulting in leadership changes and subdued operations.
Cettire Limited (ASX:CTT) Assesses Impact of US Tariff Changes
Cettire Limited (ASX:CTT) assesses the impact of new US tariffs on EU goods, affecting 41% of H1-FY25 sales.
Fisher & Paykel Healthcare (ASX:FPH) Addresses Impact of New US Tariffs
Fisher & Paykel Healthcare (ASX:FPH) outlines its response to new US tariffs, detailing operational and financial strategies.
Cochlear Limited (ASX:COH) Awaits Clarification on US Tariff
Cochlear Limited (ASX:COH) awaits clarification on new US export tariffs, expecting further details and market updates soon.
Atomos Limited (ASX:AMS) Enters $13.7m Debt Facility
Atomos Limited (ASX:AMS) secures a $13.7m debt facility to achieve cashflow positivity by FY26, avoiding equity dilution.
RPMGlobal Holdings Limited (ASX:RUL) Completes Advisory Division Divestment
RPMGlobal Holdings Limited (ASX:RUL) completes divestment of its Advisory division and plans for potential capital return to shareholders.
The Star Entertainment Group Limited (ASX:SGR) Withdraws Refinancing Proposal
The Star Entertainment Group Limited (ASX:SGR) withdraws its refinancing proposal, highlighting ongoing liquidity challenges and uncertainty about its future operations.