Tag: FDA

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides clear regulatory pathway to approval in a continuous Phase 1 / 2 / 3 study, avoiding the requirement for an additional registrational study and accelerating time to potential approval

London – 9 July 2025 - Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PS-002, enabling the initiation of a Phase I/II clinical trial in patients with primary IgA nephropathy (IgAN).

TORONTO, July 08, 2025 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialized life sciences company dedicated to the research and development of therapeutics for infectious diseases and medical countermeasures, hereby clarifies its update regarding the research study assessing Bucillamine as a potential treatment for nerve agent exposure. This study is being conducted in collaboration with Defence R&D Canada – Suffield Research Centre (“DRDC”), an agency of the Canadian Department of National Defence, which is investigating pharmacological compounds, including Bucillamine, capable of mitigating nerve agent-induced brain injury.

Lille (France), Cambridge (Massachusetts, États-Unis), Zurich (Suisse), le 8 juillet 2025 – GENFIT (Nasdaq et Euronext: GNFT), société biopharmaceutique engagée dans l’amélioration de la vie des patients atteints de maladies rares du foie pouvant engager le pronostic vital, annonce aujourd’hui le bilan semestriel du contrat de liquidité contracté avec le Crédit Industriel et Commercial.