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PRINCETON, N.J.--(BUSINESS WIRE)--BMS's Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)...

BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollm...

BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollm...

中国北京--(BUSINESS WIRE)--(美国商业资讯)-- 百奥赛图（北京）医药科技股份有限公司（以下简称“百奥赛图”，HKEX：02315）欣然宣布，其合作伙伴IDEAYA Biosciences, Inc. (Nasdaq: IDYA)，一家专注于肿瘤精准治疗药物研发的公司，已获得美国食品药品监督管理局（FDA）的临床试验用新药（IND）批准，推进同类首创B7H3/PTK7双特异性抗体偶联物（ADC）项目的I期临床试验。IDEAYA预计将在2026年第一季度开始患者入组，初步评估B7H3和PTK7共表达的实体瘤类型，包括肺癌、结直肠癌、头颈癌及卵巢/妇科肿瘤。 IDE034是一款潜在同类首创的双靶点B7H3/PTK7 TOP1 ADC，由百奥赛图自主开发，并于2024年7月授权给IDEAYA公司。此次IND获批标志着双方合作迈入重要里程碑，为推进IDE034后续的临床开发奠定基础，同时彰显了百奥赛图在双抗ADC发现与开发领域的技术实力。 百奥赛图董事长兼CEO沈月雷博士表示：“IDE034获批IND，是IDEAYA将首创TOP1 ADC管线拓展至双特异性、精准靶向策略的重要...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration (FDA) has granted a conditional approval for EXZOLT™ CATTLE-CA1 (fluralaner topical solution). This innovative product is in the newest class of parasiticides known as isoxazolines. The pour-on solution is effective for the prevention and treatment of infest...

SEOUL, South Korea--(BUSINESS WIRE)--Famenity's BF-7® gains global attention as a cognitive-health ingredient backed by more than 12 human studies and major regulatory approvals....

ACTON, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System. These updates to the Omnipod 5 algorithm set a new benchmark in tubeless diabetes technology by offering a lower 100 mg/dL Target Glucose option and a more seamless automated experie...

DURHAM, N.C.--(BUSINESS WIRE)--FDA approves expanded indication for MED-EL cochlear implants for children seven months and older with bilateral sensorineural hearing loss....

BERLIN--(BUSINESS WIRE)--Bayer announced today initiation of a Phase IIa clinical trial with BAY 3401016, an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involved in the progression of kidney damage in Alport Syndrome (AS), a rare genetic disorder. The first-in-patient study, ASSESS, is a randomized, double-blind, placebo-controlled, group-comparison trial (NCT07211685), with an extension phase, which will investigat...

NAPLES, Fla.--(BUSINESS WIRE)--Expanded indications provide surgeons flexibility for better patient outcomes, reinforcing Catalyst’s role as a leader in next-gen shoulder solutions....