Latest Fda News

Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.

Vitasora Health has expanded its partnership with The Physician Alliance Corporation from a pilot to a multi-year value-based care contract covering up to 15,000 Medicare patients, unlocking significant new revenue streams tied to patient outcomes.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.

BlinkLab has secured US Institutional Review Board approval to proceed with the main phase of its FDA 510(k) trial for an AI-powered autism diagnostic tool, marking a key step toward regulatory clearance.

Orthocell has marked a pivotal milestone with the first US surgical use of its Remplir™ nerve repair device following FDA clearance, setting the stage for commercial expansion in a $1.6 billion market.

Adherium Limited has announced a partially underwritten entitlement offer aiming to raise approximately A$4.5 million through the issuance of new shares and options at a significant discount. The capital raise is designed to accelerate patient onboarding and product development for its respiratory monitoring technology.

Neuren Pharmaceuticals has been granted a US patent for NNZ-2591 to treat Pitt Hopkins syndrome, bolstered by promising Phase 2 clinical trial results and FDA orphan drug status.

Paradigm Biopharmaceuticals has acquired Proteobioactives, securing global rights to an oral combination therapy targeting early-stage osteoarthritis in humans and animals, complementing its injectable PPS phase 3 program.

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

Adherium Limited is raising up to $4 million through a partially underwritten entitlement offer to expand its US digital health platform and recruit key personnel. The capital raise supports scaling patient onboarding and advancing its FDA-cleared smart inhaler technology.

Amplia Therapeutics has secured US ethics approval to launch a Phase 2 trial combining its drug narmafotinib with FOLFIRINOX chemotherapy for advanced pancreatic cancer, marking a key step in its clinical development.

PYC Therapeutics has gained FDA alignment on the design of its pivotal Phase 2/3 trial for VP-001, a promising treatment for the rare childhood blindness RP11. The regulator accepted the trial’s sham control arm and primary endpoints, setting the stage for a critical next step toward drug approval.