Profluent Raises $106M to Accelerate Frontier AI Models for Programmable Biology, Backed by Jeff Bezos

Profluent; AI biotech; protein design; programmable biology; Jeff Bezos; Altimeter Capital; $106M funding; Bezos Expeditions; CRISPR; biologics; Protein Atlas; synthetic biology; drug development

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

Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer

Zymeworks; royalty-driven model; Ziihera; gastric cancer; HER2; biologics; milestone payments; stock buyback; biotech strategy; Jazz Pharmaceuticals; regulatory filing

Genmab Discontinues ProfoundBio-Derived ADC GEN1107 After Acquisition, Paralleling J&J’s Ambrx Buyout Area Developments

Genmab; ProfoundBio; antibody-drug conjugate (ADC); GEN1107; PTK7; Ambrx; Johnson & Johnson (J&J); oncology; drug development; biotech acquisition; AbbVie lawsuit

Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis

Odyssey Therapeutics Appoints Dennis Dean as EVP, Head of Non-Clinical Development

Odyssey Therapeutics; Dennis Dean; Executive Vice President; Head of Non-Clinical Development; preclinical research; autoimmune diseases; drug development; biopharmaceutical

Nkarta Reports Third Quarter 2025 Financial Results and Corporate Highlights

Nkarta; Q3 2025 financial results; net loss; operating expenses; EPS; research and development; impairment; market capitalization; clinical-stage biopharma; corporate highlights

Amgen’s Repatha Reduces First-Time Cardiovascular Events by 25% in Major Clinical Trial

Amgen; Repatha; evolocumab; cholesterol drug; PCSK9 inhibitor; cardiovascular events; clinical trial; VESALIUS-CV; primary prevention; heart attack; LDL cholesterol

Ionis Claims Curative Potential for Tryngolza in Severe Triglyceride Disease

Ionis; Tryngolza; severe hypertriglyceridemia; curative potential; triglyceride reduction; acute pancreatitis; antisense oligonucleotide; FDA submission; Phase III trial; RNA-targeted therapy