Latest Fda Approval News

Memphasys delivered a record $150,000 quarterly revenue, secured its largest Felix™ supply contract with Monash IVF, and expanded into UK and Southeast Asian IVF markets, positioning for accelerated growth in FY27.

Mesoblast has completed treatment of 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain due to degenerative disc disease, with topline results expected mid-2027.

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

Botanix Pharmaceuticals has received an Intention to Grant from the European Patent Office for a patent protecting its Sofdra applicator technology, potentially extending exclusivity in Europe until 2039.

Optiscan Imaging has begun commercial sales of its InSpecta™ microscopic imaging device in the US veterinary sector following FDA clearance, marking its first clinical device launch and a strategic expansion into a $15.87 billion market.

PainChek announces the immediate departure of CEO Philip Daffas, with COO Andy Hoggan stepping in as interim leader amid a strategic pivot to boost US market growth following FDA clearance.

Orthocell has secured a strategic foothold in Thailand's $84 million nerve repair sector by appointing MediTime as exclusive Remplir distributor, leveraging established clinical networks to accelerate market penetration.

OncoSil Medical has submitted its Humanitarian Device Exemption application to the FDA for its OncoSil™ device targeting distal cholangiocarcinoma, entering the final review phase with a decision expected within 45 days.

Telix Pharmaceuticals has gained FDA alignment to advance Part 2 of its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer, setting the stage for U.S. enrolment pending regulatory approval.

Imricor Medical Systems expands its US market reach with FDA 510(k) clearances for pediatric use of its NorthStar system and Vision-MR Diagnostic Catheter, enabling radiation-free cardiac catheterisations for children.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.