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Press releases published on June 30, 2025

InstantGMP Amplía el Alcance de su Software en Español en Toda América Latina
CARY, NC, UNITED STATES, June 30, 2025 /EINPresswire.com/ -- Como parte de su creciente compromiso con el apoyo a fabricantes de productos farmacéuticos y suplementos en países de habla hispana, InstantGMP™ se enorgullece en anunciar nuevas iniciativas …

Celcuity Reports Clinical Data from Two Early Phase Studies of Gedatolisib
• In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (“mCRPC”), the six-month radiographic progression free survival (“rPFS”) rate was 66% • In a …

Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
--Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC) --No other concerns stated, including pre-clinical, clinical, or safety data --The Company identified …

Cassava Presents Promising Preclinical Simufilam Data at TSC Alliance Meeting
Data show that simufilam reduced seizure activity in a preclinical mouse model Presentation also highlights favorable human safety data from 1,929 patient Phase 3 program AUSTIN, Texas, June 30, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA …

Tonix Pharmaceuticals Announces Inclusion in the Russell 3000® and Russell 2000® Indexes
CHATHAM, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company, today announced that it will be added to the broad-market Russell 3000® Index, with …

Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in Administrative Procedure Act Litigation
DUBLIN, June 30, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of …

U.S. Department of Health and Human Services Designates Four Nutrients of Public Health Concern Validating Glucose Health, Inc. (OTC: GLUC) Patent Pending Soluble Fiber-Based Nutrition Formulation
BENTONVILLE, Ark., June 30, 2025 (GLOBE NEWSWIRE) -- Glucose Health, Inc. (OTC: GLUC), a publicly traded company specializing in diabetic nutrition and soluble fiber-based nutrition products, today commented on the U.S. Department of Health and Human …

Traws Pharma Advances Antiviral Pipeline with Multiple Regulatory Submissions
Phase 2 protocol submitted to HREC to evaluate tivoxavir marboxil (TXM) in a combined seasonal and bird flu study in the Southern Hemisphere Briefing documents submitted to FDA for a Type D meeting request to continue discussions on path forward for …

PathAI Receives FDA Clearance for AISight® Dx Platform for Primary Diagnosis
BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx*—its …

HUTCHMED Announces China Approval for ORPATHYS® in Combination with TAGRISSO® for the Treatment of Lung Cancer Patients with MET Amplification After Progression on First-Line EGFR Inhibitor Therapy
— Approval based on Phase III SACHI Trial results which showed a 66% reduced risk of progression or death as compared to platinum-based chemotherapy — — The only all-oral combination treatment option for these patients — — Consistent benefit regardless of …

Affidea Group selects b-rayZ as its preferred AI partner in breast imaging, marking strategic collaboration
THE HAGUE, The Netherlands, June 30, 2025 (GLOBE NEWSWIRE) -- In a strategic move to improve patient outcomes in breast cancer, Affidea, a leading pan-European provider of community-based polyclinics, specialist services and advanced diagnostics, is proud …

Affidea-Gruppe wählt b-rayZ als bevorzugten KI-Partner für die Brustbildgebung und geht strategische Zusammenarbeit ein
DEN HAAG, Niederlande, June 30, 2025 (GLOBE NEWSWIRE) -- Im Rahmen einer strategischen Maßnahme zur Verbesserung der Behandlungsergebnisse bei Brustkrebs gibt Affidea, ein führender paneuropäischer Betreiber von kommunalen Polikliniken sowie Anbieter von …

El Grupo Affidea elige a b-rayZ como colaborador preferente en IA para el diagnóstico mamario por imagen en una asociación estratégica
LA HAYA, Países Bajos, June 30, 2025 (GLOBE NEWSWIRE) -- En una acción estratégica para mejorar los resultados de las pacientes con cáncer de mama, Affidea, proveedor paneuropeo líder en policlínicas comunitarias, servicios especializados y diagnóstico …

Le groupe Affidea choisit b-rayZ comme partenaire d’IA privilégié en imagerie mammaire, marquant ainsi le début d’une collaboration stratégique
LA HAYE, Pays-Bas, 30 juin 2025 (GLOBE NEWSWIRE) -- Dans une démarche stratégique visant à améliorer les résultats des patientes atteintes d’un cancer du sein, Affidea, l’un des principaux prestataires paneuropéens de polycliniques de proximité, de …

Rakovina Therapeutics Highlights Strong H1 Progress and Unveils Strategic Priorities for H2 2025
VANCOUVER, British Columbia, June 30, 2025 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (“Rakovina” or the “Company”) (TSX-V: RKV) (FSE: 7JO0), a biopharmaceutical company advancing next-generation cancer therapies through artificial intelligence (AI)- …

AB Science provides an update on the renegotiation of loan repayment terms with its financial creditors
PRESS RELEASE AB SCIENCE PROVIDES AN UPDATE ON THE RENEGOTIATION OF LOAN REPAYMENT TERMS WITH ITS FINANCIAL CREDITORS AGREEMENT IN PRINCIPLE HAS BEEN REACHED ON A TWO-YEAR DEFERRAL OF REPAYMENT OF STATE-GUARANTEED LOANS SAVINGS OVER THE PERIOD WILL BE …

AB Science fait un point sur la renégociation des modalités de remboursement de ses emprunts avec ses créanciers financiers
COMMUNIQUE DE PRESSE AB SCIENCE FAIT UN POINT SUR LA RENEGOCIATION DES MODALITES DE REMBOURSEMENT DE SES EMPRUNTS AVEC SES CREANCIERS FINANCIERS UN ACCORD DE PRINCIPE A ETE OBTENU SUR UN DECALAGE DE DEUX ANS DU REMBOURSEMENT DES PRETS GARANTIS PAR L’ETAT L …

Nicox Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial
Results expected mid-August to mid-September 2025 New Drug Application (NDA) submission in the U.S. targeted for H1 2026 June 30, 2025 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international …

Nicox annonce que le dernier patient a terminé l’essai clinique de Phase 3 Denali sur NCX 470
30 Juin 2025 – publication à 7H30 Sophia Antipolis, France Nicox SA (Euronext Growth Paris : FR0013018124, ALCOX, éligible PEA-PME), une société internationale spécialisée en ophtalmologie, annonce aujourd’hui que le dernier patient a terminé l’essai …

Press release: Availability of the Q2 2025 Aide mémoire
Availability of the Q2 2025 Aide mémoire Paris, France – June 30, 2025. Sanofi announced today that its Q2 2025 Aide mémoire is available on the "Investors" page of the company's website: Second quarter 2025 (sanofi.com) As for each quarter, Sanofi …