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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...
March 26, 2025 17:00 ET | Source: Cingulate Inc.

Cingulate Inc. Reports Full Year 2024, Fourth Quarter Results, and Provides Development Update on Major Milestones Achieved

In-Person FDA Meeting Scheduled for April 2; New Drug Application Submission Targeted for Mid-2025$17.5 million increase in Working Capital; Cash Runway Extending into Q4, Well Beyond Target Date for...