COMMUNIQUÉS West-GlobeNewswire

Paratek Pharmaceuticals to Present New Data on NUZYRA® (omadacycline) at IDWeek 2025 and CHEST 2025
17/10/2025
Highlights include clinical data from Phase 3 studies in Community Acquired Pneumonia (CABP) and microbiologic data from a Phase 2 study in nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium [...]
Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation
17/10/2025
Positive opinion based on results of Phase 3 C-POST trial that show Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0. [...]
Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher for Cytisinicline for Treatment of Nicotine Dependence for E-cigarette or Vaping Cessation
17/10/2025
Potential First-in-Class Treatment for Nicotine E-cigarette or Vaping Cessation Receives Unprecedented Expedited Review Pathway One of Only Nine Therapies Chosen for the FDA’s Inaugural National Priority Voucher Program [...]
Prelude Therapeutics Announces Appointment of Katina Dorton, J.D., MBA to its Board of Directors
17/10/2025
WILMINGTON, Del., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the appointment of Katina Dorton to its Board of [...]
Rani Therapeutics Announces up to $1.085 Billion Collaboration with Chugai Pharmaceutical Co. for Multiple High-Value Therapeutics Including Rare Disease and Immunology Programs and Announces Concurrent Oversubscribed $60.3 Million Financing
17/10/2025
Rani will receive $10 million upfront payment and is eligible to receive up to $75 million in technology transfer and development milestones, up to $100 million in sales milestones and single digit royalties on product [...]
Press Release: Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia
17/10/2025
Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia Recommendation based on LUNA 3 phase 3 study demonstrating rapid and durable platelet response and significant improvements in [...]
Communiqué de presse : Wayrilz de Sanofi recommandé par le CHMP pour être approuvé par l’UE dans le cadre du traitement de la thrombocytopénie immunitaire
17/10/2025
Wayrilz de Sanofi recommandé par le CHMP pour être approuvé par l’UE dans le cadre du traitement de la thrombocytopénie immunitaire Recommandation fondée sur l’étude de phase 3 LUNA 3 démontrant une réponse plaquettaire [...]
XORTX Announces Acquisition of Renal Anti-Fibrotic Therapeutic Program from Vectus Biosystems
17/10/2025
Acquisition includes novel new chemical entity VB4-P5 with potential to address significant unmet needs in rare and large-market kidney diseases CALGARY, Alberta, Oct. 17, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc [...]
Press Release: Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease
17/10/2025
Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease Paris, October 17, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) [...]
Communiqué de presse : Sanofi fournit une mise à jour de l’examen réglementaire du Rezurock dans l’UE pour le traitement de la maladie chronique du greffon contre l’hôte
17/10/2025
Sanofi fournit une mise à jour de l’examen réglementaire du Rezurock dans l’UE pour le traitement de la maladie chronique du greffon contre l’hôte Paris le 17 octobre 2025. Le Comité des médicaments à usage humain (CHMP [...]
Climb Bio to Present Data at American Society of Nephrology (ASN) Kidney Week 2025
17/10/2025
Preclinical data for CLYM116, anti-APRIL monoclonal antibody, highlight favorable pharmacokinetic and pharmacodynamic profile, supporting development for IgA nephropathy (IgAN) Long-term follow-up clinical data for [...]
Eledon Pharmaceuticals to Present Results from Phase 2 BESTOW Trial of Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology Kidney Week 2025 Annual Meeting
17/10/2025
Conference call and webcast to discuss results to be held on November 7, 2025 at 8:00 a.m. ET IRVINE, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an [...]
Tonix Pharmaceuticals Presented Data on TNX-801 Mpox Vaccine at World Vaccine Congress–Europe 2025
17/10/2025
TNX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox TNX-801 demonstrated favorable safety, immunogenicity, and long-term protection in multiple [...]
Sight Sciences Announces Fee Schedule Establishment from Novitas Solutions and First Coast Service Options for the TearCare® Interventional Dry Eye Procedure
17/10/2025
MENLO PARK, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Sight Sciences , Inc. (Nasdaq: SGHT) (Sight Sciences or the Company), an eyecare technology company focused on developing and commercializing innovative, [...]
Tilray Brands Marks Seven Years of Cannabis Legalization in Canada with the #1 Market-Leading Position by Revenue and Pioneering Brands with Growing Market Share in the World’s Largest Federally Legal Cannabis Market
17/10/2025
TORONTO, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. ("Tilray" or the "Company") (Nasdaq: TLRY; TSX: TLRY), a global lifestyle and consumer packaged goods company at the forefront of the global cannabis, [...]
Chiesi Global Rare Diseases and Protalix Biotherapeutics Acknowledge CHMP Negative Opinion on Every Four Week Dosing Regimen of Elfabrio® (pegunigalsidase alfa) in the EU
17/10/2025
Every two weeks remains approved as a dosing regimen of Elfabrio in the EU PARMA, Italy and CARMIEL, Israel, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established [...]
Novartis Scemblix® receives positive CHMP opinion for the treatment of adults with newly diagnosed CML
17/10/2025
If approved, Scemblix will be indicated for adults with chronic myeloid leukemia (CML), both newly diagnosed and previously treated, expanding access to four times as many patients in Europe Scemblix is the only CML [...]
CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis
17/10/2025
Positive recommendation based on phase II NOBILITY and phase III REGENCY data showing Gazyva/Gazyvaro’s superiority over standard therapy alone 1,2 Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a [...]
TOLREMO therapeutics Completes First In Human Dose Escalation for TT125-802 and Presents Solid Tumor Monotherapy Results at ESMO 2025
17/10/2025
Monotherapy shows deep and durable responses in NSCLC and a best-in-class safety profile without thrombocytopenia Completion of monotherapy dose escalation part of the study will be followed by the start of combination [...]

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