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Tag: clinical study

Shanton Receives Fast Track Designation from US FDA for Refractory Gout Program

SAP-001 is Shanton's lead investigational compound with First- and Best-in-Class potential in uncontrolled gout SINGAPORE and PRINCETON, N.J., July 25, 2025 /PRNewswire/ -- Shanton Pharma,...

Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-Adapted COVID-19 Vaccine in the European Union

NEW YORK and MAINZ, GERMANY, July 25, 2025Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”2

Mainz Biomed and CARE Conclude Cooperation Agreement for Joint Care Concept for Health Insurance Companies

Mainz Biomed and CARE Conclude Cooperation Agreement for Joint Care Concept for Health Insurance Companies

Lecanemab four-year efficacy and safety data to be presented at AAIC 2025

STOCKHOLM, July 22, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab (Leqembi®), including...

UROGEN DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds UroGen Pharma (URGN) Investors of the July 28th Deadline and Urges Investors to Inquire About...

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

Biogen to Highlight Scientific Progress Across Alzheimer’s Disease at the Alzheimer’s Association International Conference 2025

CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer’s Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau.

EISAI TO PRESENT FOUR-YEAR EFFICACY AND SAFETY DATA ON CONTINUOUS TREATMENT WITH LECANEMAB AT THE ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE 2025

Latest findings from Eisai's robust Alzheimer's disease (AD) pipeline include results from lecanemab long-term data, an immunoassay for measuring amyloid-β protofibrils in cerebrospinal fluid,...

UPDATE – Daré Bioscience to Host August 6 Webinar: The DARE to PLAY™ Difference – The Sildenafil Cream That Raises the Bar

A first-of-its-kind solution for women’s arousal - the same active ingredient as in Viagra® for men - in a proprietary topical formulation demonstrated to work where women need it most

UROGEN ALERT: Bragar Eagel & Squire, P.C. Urges Investors in UroGen Pharma (URGN) to Inquire About Their Rights in Class Action Lawsuit

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

Nature Medicine Published Phase 1 Results of Innovent Biologics’ Anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

SAN FRANCISCO and SUZHOU, China, July 16, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality...

NKGen Biotech Announces New Funding to Regain Compliance with Reporting Obligations and Listing Standards

Funding in the amount of $2.0M from Japanese strategic investor, in the form of common equity PIPE with warrants.

Press Release: Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration

Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration

ArkBio’s Ziresovir Included into Pediatric RSV Drug Priority List by WHO

SHANGHAI, July 16, 2025 /PRNewswire/ -- In the newly released "Paediatric drug optimization for respiratory syncytial virus (PADO-RSV) meeting report" by Global Accelerator for...

ArkBio’s Ziresovir Included into Pediatric RSV Drug Priority List by WHO

SHANGHAI, July 16, 2025 /PRNewswire/ -- In the newly released "Paediatric drug optimization for respiratory syncytial virus (PADO-RSV) meeting report" by Global Accelerator for...

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