COMMUNIQUÉS West-GlobeNewswire

Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer
02/12/2025
Positive feedback reinforces Silexion’s trajectory toward its planned Phase 2/3 trial initiation in Q2 2026 Company plans to complete regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and in [...]
Amneal to Participate in Upcoming Investor Conferences
02/12/2025
BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced that Chirag Patel, Co-Chief Executive and President, and Tasos Konidaris, Chief Financial Officer, will [...]
DoctorBox Adds Mainz Biomed’s ColoAlert(R) to Its Portfolio
02/12/2025
DNA-based Colorectal Cancer Screening as a Home Test BERKELEY, Calif. and MAINZ, Germany, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company“), molecular genetics [...]
First U.S. Commercial Sale of KOMZIFTI™ Triggers $135 Million Milestone Payment to Kura Oncology Under Collaboration and License Agreement with Kyowa Kirin
02/12/2025
SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced [...]
BioNexus Gene Lab Corp. (Nasdaq: BGLC) Secures $500 Million Equity Facility From ARC Group International to Support Expansion of Precision Diagnostics, CDMO Operations, and Therapeutic Commercialization
02/12/2025
SHERIDAN, Wyo., Dec. 02, 2025 (GLOBE NEWSWIRE) -- BioNexus Gene Lab Corp. (“ BGLC ” or the “ Company ”), an emerging provider of precision oncology diagnostics with expanding operations across Southeast Asia, today [...]
BillionToOne to Report Third Quarter 2025 Financial Results on December 9, 2025
02/12/2025
MENLO PARK, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- BillionToOne, Inc. (NASDAQ: BLLN), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced [...]
SCIENTURE to Participate in the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025 on December 9–10, 2025
02/12/2025
COMMACK, NY, Dec. 02, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, [...]
Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small Fiber Neuropathy
02/12/2025
RICHMOND, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track [...]
SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI
02/12/2025
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 along with completion of [...]
CORRECTION: Pluristyx Launches Organoid COMMONS, Uniting Industry Leaders to Revolutionize Drug Discovery
02/12/2025
Pluristyx to lead a new public-private consortium with 9 other industry leaders to establish global standards for non-animal drug testing models Editor's Note: This press release is a replacement for the release with [...]
Gelteq to Present at Investor Summit Virtual on December 9, 2025
02/12/2025
MELBOURNE, Australia, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Gelteq Limited (Nasdaq: GELS) (“Gelteq”) today announced that Nathan Givoni, its Chief Executive Officer, will present at the Q4 Investor Summit Virtual on [...]
Fulcrum Therapeutics to Host Investor Event to Review New Clinical Data from the PIONEER trial of Pociredir in Sickle Cell Disease on December 7, 2025
02/12/2025
CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. ® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with [...]
CYIOS Corp. Appoints John O’Shea as Chief Executive Officer to Lead Next Phase of Growth and Innovation
02/12/2025
MELBOURNE, Australia and PALM BEACH, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) -- CYIOS Corp. (OTC: CYIO), a diversified holding company focused on acquiring, building, and scaling high-growth businesses in the medical, [...]
Chronic Rare Diseases in an Aging America: Why HyBryte and Federal Policy Matter Now
02/12/2025
AUSTIN, Texas, Dec. 02, 2025 (GLOBE NEWSWIRE) -- BioMedWire : Chronic conditions and rare diseases in the aging population present an urgent and expanding challenge within the U.S. healthcare system, especially as more [...]
NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine
02/12/2025
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of KETAFREE™ as a [...]
PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)
02/12/2025
Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval Pathway PRINCETON, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS [...]
rYojbaba Announces the Launch of AI-Powered Worker Risk Intelligence Platform
02/12/2025
FUKUOKA, Japan, Dec. 02, 2025 (GLOBE NEWSWIRE) -- rYojbaba Co., Ltd. (Nasdaq: RYOJ) ("rYojbaba" or the "Company"), a Japanese labor consulting and health services company, announced the launch of an AI-powered Worker [...]
PolarityBio Completes Phase III Pivotal Study of SkinTE for Diabetic Foot Ulcers
02/12/2025
PolarityBio thanks the clinical trial sites and, most importantly, the participants, for making this milestone in DFU biologic therapy development possible Final trial results anticipated in the first quarter of 2026 [...]
Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT
02/12/2025
sNDA for treatment of sBCC with Ameluz ® -PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025 First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA Primary and key [...]

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