Latest Fda Regulatory News

CurveBeam AI has reported a record quarter for HiRise™ device purchase orders, driven by a strategic expansion with Stryker in Australia and New Zealand. The company also advanced its FDA regulatory pathway for its BMD module, setting sights on mid-2025 submission.

Zelira Therapeutics has received a fourth funding tranche, bringing total investment to US$3.25 million to support FDA clinical trials of its HOPE® 1 cannabinoid medicine targeting irritability in autism spectrum disorder and Phelan-McDermid Syndrome.

Respiri Limited reports a standout December quarter marked by a 67% surge in patient program enrolments and robust revenue growth, bolstered by strategic acquisition synergies from Orb Health. The company is poised for further expansion in 2025 amid promising contract negotiations and evolving US healthcare reimbursement policies.