Temporal Concept
Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management
Gan & Lee Pharmaceuticals; Phase 3 clinical study; GRADUAL-3; once-monthly GLP-1 RA; weight management; Chinese innovation
FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months
FDA; Ascendis Pharma; TransCon CNP; navepegritide; achondroplasia; dwarfism; PDUFA; post-marketing requirement; delay; approval
Imfinzi Gains FDA Approval for Early Gastric and GEJ Cancers; BiomX Nebulizer Faces FDA Scrutiny
Imfinzi; FDA approval; gastric cancer; gastroesophageal cancer; perioperative; BiomX; nebulizer; clinical hold
BostonGene to Showcase Transformative Impact of AI-Driven Profiling with Six Abstracts at the 67th American Society of Hematology Annual Meeting & Exposition
BostonGene; AI-driven molecular profiling; hematology; 67th ASH Annual Meeting; immune profiling; multiple myeloma; patient stratification; clinical trials; biomarkers; precision oncology
Novo Nordisk’s Semaglutide Misses Key Goals in Closely-Watched Alzheimer’s Disease Phase 3 Trials
Novo Nordisk; semaglutide; Alzheimer’s disease; EVOKE trial; EVOKE+ trial; clinical trial failure; Rybelsus; GLP-1 drugs; phase 3; biomarkers; cognitive decline
AstraZeneca Onshores Rare Disease Portfolio as Part of $50B US Investment Pledge
AstraZeneca; rare disease portfolio; onshoring; US investment; biomanufacturing; $50 billion pledge; Virginia facility; Maryland investment; R&D expansion
FDA Breakthrough Designations Lead to Priority Reviews, Report Finds
FDA; breakthrough therapy designation; priority review; drug approval; expedited pathway; biotechnology innovation; rare diseases; oncology; CDER; regulatory science
Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)
Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug
Roche’s Oral SERD Giredestrant Delays Early Breast Cancer Recurrence in Late-Stage Trial
Roche; oral SERD; giredestrant; Phase 3 trial; early breast cancer; ER-positive; HER2-negative; disease-free survival; adjuvant therapy; recurrence prevention
Jazz and Zymeworks Bispecific Antibody Zanidatamab Delivers Practice-Changing Results in Stomach Cancer Study
Jazz Pharmaceuticals; Zymeworks; zanidatamab; bispecific antibody; HER2; gastroesophageal adenocarcinoma; stomach cancer; phase 2 trial; phase 3 HERIZON-GEA-01; overall survival; progression-free survival; chemotherapy; practice-changing; Orphan Drug designation