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FDA Opens Public Docket on Drug Repurposing to Close Labeling Gaps for Approved Medicines

FDA opens a public docket on drug repurposing, targeting labeling updates for approved medicines across metabolic, rare, and neurodegenerative disease areas.

Vaibhavi M. | May 11, 2026

Reunion Neuroscience Gains FDA Breakthrough Designation for Luvesilocin After Phase 2 PPD Trial Success

Reunion Neuroscience targets 2026 Phase 3 initiation for luvesilocin in PPD after FDA Breakthrough Designation and single-trial registrational agreement.

Vaibhavi M. | May 11, 2026

FibroBiologics Advances Fibroblast Platform Into Hantavirus Pulmonary Syndrome With No Approved Treatments

FibroBiologics expands its fibroblast platform into Hantavirus pulmonary syndrome, leveraging ARDS preclinical data where no approved treatments exist.

Vaibhavi M. | May 11, 2026

Abeona Therapeutics Activates CHOP as Sixth Qualified Treatment Center for ZEVASKYN Gene Therapy

Abeona Therapeutics adds CHOP as its sixth ZEVASKYN Qualified Treatment Center, expanding autologous gene therapy access on the US east coast.

Vaibhavi M. | May 11, 2026

Miror Therapeutics Signs Awareness Partnership with BESCOM and Soham Foundation for Menopause Education

Miror Therapeutics partners with BESCOM and Soham Foundation to deliver menopause and HRT awareness at BESCOM's Bengaluru headquarters.

Vaibhavi M. | May 11, 2026

Abbott Launches TriClip Minimally Invasive Tricuspid Regurgitation Therapy in India

Abbott brings catheter-based tricuspid valve repair to India, creating new device governance and procurement obligations for cardiac programs.

Vaibhavi M. | May 11, 2026

Robocath Completes First-in-Human Enrollment for Next-Generation Robotic PCI System in France

Robocath closes first-in-human enrollment for its robotic PCI platform in France, advancing toward regulatory submission.

Vaibhavi M. | May 11, 2026