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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vedanta Biosciences, a late clinical-stage biopharmaceutical company developing microbiome-based oral therapies for gastrointestinal diseases, today announced that the independent Data Monitoring Committee (DMC) overseeing RESTORATiVE303, the pivotal Phase 3 trial of VE303 for prevention of recurrent Clostridioides difficile infection (CDI), has completed its first prespecified interim analysis and recommended that the study continue without modification. The...

ROCKVILLE, Md.--(BUSINESS WIRE)--CTIS, Inc., with more than 30 years of experience in Health IT and clinical research informatics expertise for government and industry clients, today announced the commercial availability of Trial SafetyXchange. The cloud-based software-as-a-service (SaaS) solution is purpose-built to help small and mid-size pharmaceutical companies, biotech firms, and contract research organizations (CROs) seamlessly convert Individual Case Safety Report (ICSR) files from the p...

SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Tenpoint Therapeutics, a leading ophthalmic manufacturer, and PHIL Inc., an all-in-one digital hub and Direct-to-Patient platform, today announced the launch of a Direct-to-Patient (DTP) cash program for YUVEZZI™, the first and only dual-agent prescription eye drop FDA-approved for the treatment of presbyopia. Why Direct-to-Patient Access Matters for Presbyopia Patients Access and adherence remain persistent challenges in ophthalmology, where treatments are o...

HOUSTON--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, today announced that founder Howard Berman, Ph.D., has stepped down as Executive Chairman and as a member of the Board, and that Mark H. Pavao has been appointed to the Board as an independent director. Dr. Berman became Executive Chairman in November 2024 a...

ST. LOUIS--(BUSINESS WIRE)--Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that the U.S. Food and Drug Administration (FDA) has selected Sofi-cel, an investigational allogeneic CAR-T cell therapy, to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. Wugen was invited by the FDA to participate in the CDRP program,...

WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the EMERALD-3 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with IMJUDO® (tremelimumab-actl), lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolization. At this in...

WOBURN, Mass.--(BUSINESS WIRE)--CanWell Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAN016, a HER2-targeting dual-payload ADC. The company will initiate a Phase I clinical study to evaluate CAN016 in solid tumor patients who have experienced disease progression following prior ADC therapies. About CAN016 CAN016 is an ADC in development by CanWell Pharma Inc. for ADC pre-treated solid tumors. Develope...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA® (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the European Union (EU) for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1 and who have received one or two prior systemic treatment regimens. T...

ミネソタ州メープルグローブ--(BUSINESS WIRE)--（ビジネスワイヤ） -- 次世代の経カテーテル弁置換技術の開発に取り組む非公開の医療機器企業VDYNE, Inc.（以下「VDYNE」または「同社」）は、同社の経カテーテル三尖弁置換（Transcatheter Tricuspid Valve Replacement、以下「TTVR」）システムを評価するピボタル臨床試験について、米国食品医薬品局（FDA）より治験医療機器適用免除（IDE）承認を取得したと発表しました。 IDE承認により、重度の三尖弁逆流症（TR）患者におけるVDYNEシステムの安全性および有効性を評価するため、米国の主要医療機関においてピボタル試験の開始が可能となります。 「これはVDYNEにとって画期的なマイルストーンであり、重度の三尖弁逆流症患者に強く求められている治療法の提供に向けた重要な一歩です」と、最高経営責任者（CEO）のマイク・バックは述べました。「現在、当社は着実な臨床試験の遂行に注力するとともに、主要な治験責任医師らと連携し、本分野を進展させ患者ケアを向上させる高品質なデータの創出に取り...

MAPLE GROVE, Minn.--(BUSINESS WIRE)--VDYNE, Inc. (“VDYNE” o “la Società”), un'azienda privata specializzata in dispositivi medici che sviluppa tecnologie di sostituzione transcatetere della valvola di nuova generazione, oggi ha reso noto che la Food & Drug Administration (FDA) statunitense ha approvato una esenzione di dispositivo sperimentale (investigational device exemption, IDE) per lo studio clinico pivotale dell'azienda volto a valutare il suo sistema di sostituzione transcatetere del...