Latest Us Fda News

Control Bionics has secured MHRA registration for its NeuroStrip device, unlocking commercial supply in Great Britain and launching early trials with leading UK institutions.

Prescient Therapeutics launches a $7 million Share Purchase Plan at an 18.8% discount to fund advancement of its PTX-100 cancer therapy beyond a key 2026 Dose Optimisation Committee review.

AdAlta Limited (ASX:1AD) has progressed its ‘East to West’ cellular immunotherapy strategy by securing its first CAR-T asset, advancing Australian manufacturing and US FDA regulatory engagement, while raising A$5.3 million in FY2026 and reporting a net loss of $4.68 million.

Prescient Therapeutics cut its net loss by 4.4% to $7 million in FY26 while expanding its PTX-100 Phase 2a trial across three continents and securing key regulatory designations in Europe and the US.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

Percheron Therapeutics announces Dr Michael Baker as incoming CEO, replacing Dr James Garner who steps down after three years. Baker’s appointment aligns executive incentives with shareholder value as the company prepares for a pivotal HMBD-002 clinical trial.

Acrux Limited spotlighted its Female Testosterone Metered Dose Transdermal System (MDTS) at the Bioshares Biotech Summit, revealing positive Phase II data and outlining a clear regulatory and commercial roadmap targeting Hypoactive Sexual Desire Disorder (HSDD) in women.

Dimerix CEO Dr Nina Webster detailed the company’s geographic and product diversification at the Bioshares Summit, spotlighting the commercial potential of DMX-200 and the newly acquired Phase 2 asset DMX-652 targeting acute kidney injury.

AdAlta’s lead CAR-T therapy EW-001 has achieved a rare clinical milestone with one mesothelioma patient remaining cancer-free two years after treatment, and a second reaching one-year survival, underscoring the therapy’s potential durability in a notoriously difficult cancer.

Clarity Pharmaceuticals bolsters its commercial readiness with a $178.3 million cash reserve and a key US manufacturing agreement, while clinical trials for its prostate cancer imaging and therapeutic agents progress with promising data.

Zelira Therapeutics has raised nearly US$33 million into its HOPE® 1 special purpose vehicle, valuing the SPV at about US$66 million post-money. The funds will advance FDA regulatory submissions and Phase 1 clinical trials for its autism-targeting cannabinoid drug.

Island Pharmaceuticals has marked a major step forward in its antiviral program with the start of GMP manufacturing for Galidesivir, expanded USAMRIID collaboration, and FDA orphan drug designation. Regulatory approvals for compassionate use in Uganda’s Ebola outbreak and a new dose optimisation study with Texas Biomed further de-risk the pathway to approval.