Browsing Tag
United States Food and Drug Administration
193 posts
Palvella Therapeutics (NASDAQ: PVLA) rebounds 15% as investors reassess FDA path
Palvella Therapeutics is recovering from a sharp selloff as investors separate its advancing QTORIN rolling application from uncertainty surrounding a second indication.
Telix Pharmaceuticals (ASX: TLX) revenue tops $247m as pipeline spending rises
Telix Pharmaceuticals revenue is accelerating, but rising R&D spending and FDA decisions will determine whether ASX: TLX can regain its premium.
Mesoblast (ASX: MSB; Nasdaq: MESO) CEO invests A$2.73m as Ryoncil growth shifts focus to execution
Mesoblast Chief Executive Silviu Itescu has paid A$2.73 million to increase his ownership, adding an alignment signal as Ryoncil sales and late-stage programs reshape the company.
Dimerix (ASX: DXB) acquires Phase 2-ready DMX-652 as acute kidney injury deal reshapes renal pipeline
Dimerix has acquired a Phase 2-ready acute kidney injury candidate with an open United States clinical application, giving the biotechnology company a nearer-term catalyst beyond its long-running ACTION3 programme.
Takeda’s zasocitinib shows high clearance rates at difficult psoriasis sites
Scalp and palmoplantar clearance rates approached 70% to 77%, but regulatory review, safety labelling and market access will determine the commercial impact.
NeuroLexIQ adds Canary Speech voice AI to injury intake, but can an early signal withstand legal scrutiny?
NeuroLexIQ will use Canary Speech voice analysis to flag possible concussion cases during the first attorney intake call. The pilot could accelerate referrals, but clinical validation, informed consent and evidentiary discipline will determine its credibility.
Mesoblast (ASX: MSB) clears key treatment milestone ahead of mid-2027 back pain trial readout
Mesoblast has treated at least 300 patients in MSB-DR004, starting the final 12-month clock towards a mid-2027 readout and potential United States filing. The milestone strengthens execution visibility, but it does not provide new efficacy data.
Island Pharmaceuticals (ASX:ILA) shares rise as Texas Biomed expands Galidesivir regulatory pathway
Island Pharmaceuticals adds Texas Biomed to Galidesivir’s FDA Animal Rule program, expanding dose evidence while raising execution and timing stakes now.
Vectus Biosystems (ASX:VBS) appoints Cardinal Health Regulatory Sciences for VB0004 FDA pathway
Vectus Biosystems has formalised its United States regulatory strategy for VB0004, but financing, clinical execution and evidence of human antifibrotic activity remain the decisive valuation tests.
Scancell Holdings (LSE:SCLP): Can a Nasdaq deal fund its pivotal melanoma trial?
Scancell has strong melanoma data, but Phase 3 still needs funding. A Nasdaq deal could reset LSE:SCLP, or leave investors facing dilution and deal risk.