Newsroom | 11783 results

東京--(BUSINESS WIRE)--（ビジネスワイヤ） -- 好中球/リンパ球比（NLR）は、ミッション中の宇宙飛行士の健康状態、加齢性疾患、炎症老化、寿命、がんの予後を判断する重要なバイオマーカーです。アウレオバシジウム・プルランスが産生する2種類のベータグルカン、AFO-202菌株由来の「ニチブライト」とN-163菌株由来の「ニューリフィックス」の摂取を行った前臨床試験および臨床試験では、NLR値の安全かつ効果的な低下が確認されており、これらのベータグルカンが宇宙飛行中の健康を維持するうえで役立つ可能性があると考えられます。今回、このNLRの数値を下げることで「Me-ByoまたはMi-Byo（未病）」 を効果的に行い、健康寿命と平均寿命のギャップを埋める可能性について、Frontiers in Immunology誌に論文が発表されました。また、「ニューリフィックス」の単独摂取でジストロフィン発現の増強を促すことがNature Scientific Reports誌に発表され、宇宙ミッション中の筋肉の減少を防ぐ可能性も期待されます。 宇宙飛行士がストレス、炎症、免疫障害につ...

NEW YORK--(BUSINESS WIRE)--Vent Creativity, a digital-twinning based medical software company, announced the FDA clearance of their new AI driven software solution, Hermes Knee, which uses deep learning (DL) to generate surgical plans for mechanical, kinematic, and anatomical alignment techniques for total and partial knee arthroplasty procedures. Vent℠ Hermes is built on the Minerva platform, capable of planning and analyzing procedures for research applications in other indications. The syste...

DUBLIN--(BUSINESS WIRE)--The "FDA Inspection" training has been added to ResearchAndMarkets.com's offering. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body lan...

DALLAS--(BUSINESS WIRE)--Secretome Therapeutics, a pioneering company in the field of regenerative medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STM-01, the company’s neonatal cardiac progenitor cell (nCPC) therapy, for the treatment of Heart Failure with Preserved Ejection Fraction (HFpEF). HFpEF is a debilitating condition affecting millions of patients worldwide, characterized by impaired heart relaxation and elevated left ve...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA® (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failu...

NANJING, China--(BUSINESS WIRE)--Today, Triastek announces that on February 27, 2025 a proprietary 3D-printed non-vitamin K antagonist oral anticoagulant (NOAC) product, T20G, received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). This regulatory milestone follows the prior IND clearance of this product by China's National Medical Products Administration (NMPA) in January 2024. Atrial fibrillation (AF), the most common type of treated heart arrhythmi...

DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet diseases, presents preclinical data supporting repeat dosing of PBGENE-HBV in the ELIMINATE-B trial to treat patients with chronic HBV. Even with today’s standard of care, an estimated 15% to 40% of patients with HBV infections may develop complications, such as cirrhosis, liver f...

NEW YORK & VALENCIA, Spain & CAMBRIDGE, England--(BUSINESS WIRE)--Quibim, a global company pioneering imaging biomarkers for precision medicine, announces that its prostate cancer lesion detection capability of its flagship QP-Prostate® CAD solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance marks a significant milestone in Quibim’s mission to enhance prostate cancer detection and treatment. QP-Prostate, which uses algorithms trained on actual...

CHICAGO--(BUSINESS WIRE)--MAIA Biotechnology Receives USAN Council Approval for “Ateganosine” as Nonproprietary Name for Anticancer Agent THIO...

NEW YORK--(BUSINESS WIRE)--Flatiron Health, a healthtech company transforming clinical research through technology that integrates research into everyday care, today announced a collaboration with NRG Oncology (NRG), a clinical research consortium in the National Cancer Institute (NCI)’s National Clinical Trials Network (NCTN) comprised of over 1,300 worldwide research sites, to deploy Flatiron Clinical Pipe™ in a multicenter NRG clinical trial. Flatiron Clinical Pipe™, a cutting-edge electroni...