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CAMBRIDGE, Mass.--(BUSINESS WIRE)--NextPoint Therapeutics, a clinical-stage biotechnology company developing a new world of precision therapeutics through its leading scientific work on the novel B7-H7 axis, today announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate clinical development of NPX372, a first-in-class T cell engager (TCE) for the treatment of patients with solid tumors. B7-H7 is highly specific to tumo...

NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced finalization of a protocol amendment to the ongoing global SIGMA study (also known as G203; NCT05303519) of safusidenib that expands it to a Phase 3 trial. SIGMA is evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-risk or high-grade IDH1-mutant astrocytoma...

SAN ANTONIO--(BUSINESS WIRE)--bioAffinity Technologies appoints nationally recognized pulmonary and lung cancer authorities to its Medical and Scientific Advisory Board...

SAN DIEGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Iambic, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, today announced a multi-year technology and discovery collaboration agreement with Takeda that will use Iambic’s industry leading AI drug discovery models to advance a select set of high-priority small molecule programs, initially in Takeda’s Oncology and Gastrointestinal and Inflammation therapeutic areas....

EMERYVILLE, Calif.--(BUSINESS WIRE)--Estrella Immunopharma, Inc. (Nasdaq: ESLA, ESLAW) (“Estrella” or the “Company”), a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, presented positive STARLIGHT-1 Phase I results at the 2026 ASTCT & CIBMTR Tandem Meetings (American Society for Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research). The oral prese...

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today announced it has received FDA 510(k) clearance for eyonis® LCS, its AI/ML-powered computer-aided detection and...

ST. LOUIS--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a Final Written Decision following inter partes review (IPR), finding all 10 challenged claims of Exact Sciences’ U.S. Patent No. 11,970,746 (the ’746 patent) unpatentable. This decision follows the PTAB’s July 2025 Final Written...

ウィスコンシン州マディソン--(BUSINESS WIRE)--（ビジネスワイヤ） -- 中国国家薬品監督管理局（NMPA）は、中国において、OncoMate® マイクロサテライト不安定性（MSI）検出キットを第III類の体外診断用医療機器として承認しました。本製品は、メルク・アンド・カンパニー（米国ニュージャージー州ローウェイ）の抗PD-1抗体療法であるKEYTRUDA®（ペムブロリズマブ）治療の対象となる、MSI-High（MSI-H）の固形がん患者を特定するためのコンパニオン診断薬としての使用を目的としています。また、プロメガのコンパニオン診断薬として初めてNMPAの承認を取得しました。 「今回の承認は、中国における、より個別化された効果的ながん治療の実現に向けた一歩となります」と、プロメガのグローバル臨床マーケット・ディレクターであるアロク・シャルマは述べています。「当社は、革新的な技術や人命を救う効果的な治療法へのアクセス拡大につながる世界的なソリューションを提供するために、製薬企業と協業できることを誇りに思います。」 中国では、依然として世界でも特に高いがん負担に直面して...

MADISON, Wisconsin, USA--(BUSINESS WIRE)--Chinas nationale Aufsichtsbehörde für Medizinprodukte, NMPA (National Medical Products Administration), hat das OncoMate® -Kit zum Nachweis von Mikrosatelliteninstabilität (MSI) als In-vitro-Diagnostikum der Klasse III in China zugelassen. Das Kit soll als Begleitdiagnostikum zur Identifizierung von hochgradiger Mikrosatelliteninstabilität (MSI-H) bei Patienten mit soliden Tumoren für die Behandlung mit KEYTRUDA® (Pembrolizumab) dienen, einer Anti-PD-1-...

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therap...