Latest Fda Approvals News

Telix Pharmaceuticals showcased its global theranostic radiopharmaceutical portfolio, highlighting FDA approvals, clinical progress, and a robust commercial expansion plan at its 2025 Investor Day.

Cyclopharm Limited has secured the maximum five-year U.S. patent extension for its flagship Technegas® Kit, extending market exclusivity to 2031 and reinforcing its strategic foothold in pulmonary imaging.

Botanix Pharmaceuticals has secured a US$30 million debt facility from Kreos Capital, bolstering its financial position to commercialize Sofdra™ and pursue platform expansion opportunities.

EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.

INOVIQ Limited has revealed promising data for its EXO-OC™ ovarian cancer screening test, demonstrating exceptional accuracy and flawless detection of early-stage cancers. This innovation could transform early diagnosis and treatment outcomes for women worldwide.

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.

PainChek Limited has secured a pivotal reseller and integration deal with Eldermark Software, positioning its AI-driven pain assessment app for a major US market rollout pending FDA approval.

EBR Systems has announced a fully underwritten A$55.9 million capital raise alongside a Security Purchase Plan to fund the commercial rollout of its FDA-approved WiSE CRT System, targeting a US$3.6 billion market opportunity in cardiac resynchronization therapy.

EBR Systems has raised A$55.9 million through a fully underwritten placement to fund the commercial rollout of its FDA-approved wireless cardiac pacing system, with plans for a limited market release in H2 2025 and expanded distribution in 2026.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

Cynata Therapeutics confirms that the recent FDA orphan-drug exclusivity granted to Ryoncil® will not block approval of its CYP-001 therapy, highlighting key differences in drug composition and patient indications.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.