Latest Fda Approval News

Atomo Diagnostics has responded to ASX queries confirming it first held market-sensitive information after Lumos Diagnostics’ FDA CLIA waiver approval for FebriDx. The company defended its trading halt and capital raise timing, asserting full compliance with ASX Listing Rules.

Immuron Limited’s unaudited Q3 FY26 sales rose 16% to AUD 1.5 million, driven by Travelan’s expanding footprint in Australia, Canada, and the US despite a stronger Australian dollar.

Botanix Pharmaceuticals has agreed to terms with Piramal to establish an alternate supplier for the active ingredient in Sofdra, aiming to reduce costs by up to 40% and strengthen its supply chain.

ReNerve has moved its NervAlign Nerve Guide Matrix into stage 3 of commercial development, a key step toward FDA submission and eventual market entry. This progress supports the company’s ambition to provide surgeons with an alternative to donor nerves for repairing severe peripheral nerve injuries.

Mesoblast has acquired exclusive rights to a patented chimeric antigen receptor platform designed to enhance the targeting and potency of its mesenchymal stromal cell therapies, aiming to expand treatment options for inflammatory and autoimmune diseases.

AVITA Medical’s Cohealyx-I study interim results show a significant acceleration in skin grafting time for full-thickness wounds, reducing mean time to graft from 33.2 to 13.6 days. The ongoing trial’s promising data could reshape wound care protocols.

PainChek has secured a landmark agreement with Sabra Health Care REIT to deploy its AI-powered pain assessment across up to 20,000 beds in North America, marking a pivotal step in its US expansion.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) has received FDA Investigational New Drug clearance to initiate a pivotal clinical trial of its cell therapy Ryoncil in children with Duchenne Muscular Dystrophy, aiming to address inflammation-driven disease progression.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals has broadened availability of DAYBUE STIX, a new FDA-approved powder formulation of trofinetide for Rett syndrome, in the US. Early caregiver feedback and expert consensus highlight its potential role in personalised patient care.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net sales of US$30.3 million for its FDA-approved cellular therapy Ryoncil in the March quarter, bringing total revenue since launch close to US$100 million. Strong sales in February and March offset January’s seasonal dip.

AVITA Medical has lodged a new $200 million shelf registration with the SEC, renewing its capacity to issue various securities in the US market. While no immediate capital raising is planned, this move preserves the company’s financial agility for future growth opportunities.