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FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients Compelling efficacy data to date...
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Industry Veteran Bryan Downey Named Chief Commercial Officer NDA Accepted with May 2026 PDUFA Date Commercial Supply Agreement Executed KANSAS CITY, Kan., Nov. 13, 2025 (GLOBE NEWSWIRE) --...
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Appointment builds on recent FDA acceptance of New Drug Application for review and advances Cingulate’s transition toward commercialization pending FDA approval Company also strengthens its cash...
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PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices MINNEAPOLIS and...
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Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS...
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Innovation from PIC provides solution to devastating animal disease. Research finds that consumers express support for this gene-edited innovation.
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TORONTO, Aug. 26, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the...
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Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026 KANSAS CITY, Kan., Aug. 19,...
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TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the...
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Novel, single pill, triple combination with a standard dose and two lower doses that can deliver the efficacy benefits of combination therapy, with an established safety profile and good...