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Alys Pharmaceuticals receives IND clearance for Phase 2a trial of first genetic medicine program in dermatology
BOSTON, MA, USA and LAUSANNE, Switzerland I 4, 2025 I Alys Pharmaceuticals, Inc. ("Alys"), an immune-dermatology focused company, today announces ...
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Algiax Announces Positive Data from Phase 2a Proof of Concept Study Evaluating AP-325 in Patients with Neuropathic Pain
DÜSSELDORF, Germany I 04, 2025 I Algiax Pharmaceuticals, a clinical-stage biotech company focused on developing innovative treatments for chronic ...
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Pfizer’s BRAFTOVI® Combination Regimen Significantly Improved Progression-Free Survival and Overall Survival in Phase 3 BREAKWATER Trial
NEW YORK, NY, USA I 03, 2025 I Pfizer Inc. (NYSE: PFE) today announced positive topline results from the progression-free survival (PFS) analysis of ...
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HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
This study will evaluate HCW9302 in patients with moderate to severe alopecia areata. MIRAMAR, FL, USA I 03, 2025 I HCW Biologics Inc. (“HCWB” or the “Company”) ( ...
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Bayer files for approval of finerenone in heart failure in the EU
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients ...
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Inhalon Biopharma Announces First-of-its-Kind Inhaled Antibody Treatment for RSV to Enter Human Clinical Trials
New at-home RSV treatment represents a potential breakthrough in addressing the burden of respiratory diseases, especially in vulnerable pediatric and elderly ...
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U.S. FDA approves Celltrion’s AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®
JERSEY CITY, NJ, USA I January 30, 2025 I Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA ® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and ...
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Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis
Robust evidence of the clinical benefit of WINREVAIR demonstrated in the STELLAR and ZENITH studies resulted in a loss of clinical equipoise in the HYPERION study RAHWAY, NJ, USA I January 30, 2025 I ...
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Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
— JOURNAVX is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years — — JOURNAVX is an effective and well-tolerated ...
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Gameto Announces FDA IND Clearance for Fertilo, the First iPSC-Based Therapy to Enter U.S. Phase 3 Clinical Trials
AUSTIN, TX, USA I January 30, 2025 I Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S. Food and Drug Administration (FDA) has ...
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Tubulis Announces First Patient Dosed in Phase I/IIa Trial Evaluating ADC TUB-030 in Advanced Solid Tumors
MUNICH, Germany I January 30, 2025 I Tubulis announced today that its second drug candidate, TUB-030, has entered clinical evaluation with successful dosing of the first patient in the 5-STAR 1-01 ...
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Shionogi Announces Positive Results from Phase 2 Trial of Respiratory Syncytial Virus Oral Antiviral Candidate S-337395
In the highest dose group, there was an 88.94% reduction in viral load (P<0.0001) OSAKA, Japan I January 30, 2025 I Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao ...