Tag: FDA

EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announced the submission of two major regulatory applications for its ARC-EX System. The Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand its indication for home use. In parallel, ONWARD has filed an application with the notified body for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) to enable commercialization of the ARC-EX System in the EU. Completed in June, these submissions represent significant milestones as the Company advances its mission to bring breakthrough therapies to people with SCI around the world.

LAUSANNE, Switzerland and COPENHAGEN, Denmark, July 01, 2025 (GLOBE NEWSWIRE) -- ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women’s health, today announced that the first participant has been included in the company’s Phase 2 clinical trial of its lead candidate RPN-001 (leflutrozole), an orally administered aromatase inhibitor in development for the treatment of male infertility (https://clinicaltrials.gov/study/NCT06993155?term=Leflutrozole&rank=1).

NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor^® (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation.

SEATTLE and VANCOUVER, British Columbia, June 30, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced the closing of its underwritten public offering of 15,000,000 shares of its common stock and accompanying common warrants to purchase up to 16,766,666 shares of common stock at a public offering price of $3.00 per share and accompanying warrant, which includes common warrants to purchase up to 1,766,666 shares issued upon the partial exercise by the underwriters of their option to purchase additional shares of common stock and/or accompanying warrants. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $45.0 million.

TORONTO, ONTARIO, June 30, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI; TSX: CSCI) (“COSCIENS” or the “Company”), a life sciences company developing and commercializing a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today announced the voting results on the items of business considered at the virtual annual general and special meeting of shareholders of the Company (the “AGSM”) held today.