Pathway Labs announced its public launch of EchoNext, the world’s first FDA-approved AI detection tool that reads standard 12-lead electrocard...
First PMDA-approved molecular residual disease (MRD) test in Japan, supporting the use of Signatera in the adjuvant setting Commercial launch expected...
First regulatory approval for iza-bren (BL-B01D1), a first-in-class EGFR×HER3 bispecific antibody-drug conjugate (ADC) Represents an important n...
Wayrilz is a BTK inhibitor that works through multi-immune modulation to help address the underlying causes of immune thrombocytopenia (ITP) Approval ...
Contamination control is no longer viewed solely through the lens of compliance. Across today's biopharmaceutical manufacturing landscape, it has become a ...
NDA submission supported by positive Phase 3 data recently published in JAMA Neurology. Ecopipam is a first-in-class selective dopamine D1 receptor an...
Biogen Inc. (Nasdaq: BIIB) and RayThera Inc., a private biotechnology company focused on discovering and developing small molecule therapies in immunolog...
Filing acceptance based on data from the phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of dis...
Volta Labs, the genomics applications company transforming next-generation sequencing (NGS) sample preparation through automation, announced the launch o...
Used as a predictive biomarker, the first-of-its-kind VENTANA MMR RxDx Panel helps identify cancer patients eligible for treatment ...
Strategic partnership integrates Pluristyx's clinical-grade iPSC platform into Made Scientific's CDMO services, giving developers a single-source path fr...
ADC Therapeutics SA announced topline data from its Phase 3 LOTIS-5 confirmatory trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in co...
Orphan Drug Designation (ODD) recognizes Duchenne muscular dystrophy as a rare disease with significant unmet medical need without an established treat...
Approval Based Upon Phase 3 DeLLphi-304 Trial Demonstrating 40% Reduction in Risk of Death with IMDYLLTRA Compared to Chemotherapy Novel Treatment...
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