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November 10, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Names Industry Veteran Bryan Downey Chief Commercial Officer to Lead Launch Preparation for CTx-1301

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...
November 03, 2025 07:00 ET | Source: Anteris Technologies Global Corp.

FDA Approves Anteris’s DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

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...
October 14, 2025 08:00 ET | Source: Cingulate Inc.

FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date

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...
September 02, 2025 09:00 ET | Source: PIC

Innovation from PIC provides solution to devastating animal disease

Innovation from PIC provides solution to devastating animal disease. Research finds that consumers express support for this gene-edited innovation.
August 26, 2025 08:00 ET | Source: PharmaTher Holdings Ltd.

PharmaTher Provides Corporate Update Following FDA Approval of Ketamine (KETARx™)

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...
August 19, 2025 08:45 ET | Source: Cingulate Inc.

Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights

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,...
August 11, 2025 09:26 ET | Source: PharmaTher Holdings Ltd.

PharmaTher Announces FDA Approval of Ketamine (KETARx™)

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...
June 09, 2025 07:00 ET | Source: George Medicines

George Medicines announces FDA approval of WIDAPLIK™ (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment

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...
May 22, 2025 14:12 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis’ ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older

FDA has approved the supplemental New Drug Application (sNDA) for ZORYVE® foam 0.3% for the treatment of plaque psoriasis
May 14, 2025 08:00 ET | Source: Cingulate Inc.

FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301

Pre-NDA Minutes from April 2, 2025, Meeting Received NDA Submission Planned this Summer KANSAS CITY, Kan., May 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical...