Development

GSK’s purchase of RAPT underscores growing biopharma focus on durable biologics designed to reduce dosing burden in food allergy and immunology care.

In 2026, AI and automation are anticipated to solve talent gaps and economic shifts to drive resilient drug discovery and manufacturing.

The approval of aflibercept for visual impairment from macular edema following retinal vein occlusion is based on clinical data that suggests higher-dose anti-VEGF therapy can preserve vision while extending dosing intervals.

As biologic modalities grow more complex and timelines compress, integrated, end-to-end CDMO partnerships are emerging as a strategic differentiator to enable biopharma companies to reduce risk, accelerate development, and maintain quality and regulatory continuity across the full product lifecycle.

A new FDA draft guidance signals broader acceptance of Bayesian methods, shaping clinical trial design, efficiency, and regulatory strategy in drug development.

EU approval of a prefilled Shingrix syringe streamlines vaccine delivery, while Phase III data position bepirovirsen as a potential functional cure for hepatitis B.

In a new team-up, MD Anderson and SOPHiA GENETICS will apply advanced analytics to cancer testing to improve complex data interpretation for clinical use.

The CDC has narrowed pediatric vaccine guidance, resetting evidence expectations and signaling potential shifts in vaccine uptake and market demand.

China’s authorization of GSK’s Nucala (mepolizumab) for treating COPD signals regulatory momentum for precision respiratory medicines in the country.

The company’s Phase III setrusumab trials in osteogenesis imperfecta missed fracture endpoints but showed strong bone density gains.

Key 2025 FDA draft and final guidances emphasize the modernization of biotech regulations, acceleration of rare-disease therapies, and streamlining of biosimilar pathways.

A look at interchangeable biosimilars gaining FDA approval, the growth in global partnerships, and the rising biologics patent cliff.

EMA Director sees new legislation as an opportunity to revamp policies.

Advances in precision analytics have pushed the needle forward in characterizing and assessing the safety and quality of next-gen biologics.

This past year in biologics was marked by clinical trends, manufacturing scalability, and regulatory acceleration for antibody therapeutics.

Norgine has gained regional rights to Vir Biotechnology’s hepatitis delta drug pairing, strengthening late-stage antiviral development across Europe, Australia, and New Zealand.

European regulators authorize AstraZeneca’s anifrolumab pen for lupus, reinforcing industry momentum toward self-injected biologics and decentralized immunology care.

Surface modification with targeting ligands increases the advantages offered by nanoscale delivery.

Fondazione and Orphan Therapeutics outline a US access model for Waskyra, highlighting new approaches to manufacturing, distribution, and sustainability.

Charles River has launched a second cohort to speed CGT innovation with technical guidance and scalable manufacturing support.

The new GSK–Oxford BioTherapeutics partnership capitalizes on proteomics-driven oncology target discovery for advancing antibody therapeutics development.

FDA’s approval of the first Wiskott-Aldrich gene therapy signals a shift in manufacturing and regulatory standards for rare-disease CGTs.

FDA’s clearance of a chemically enhanced stem cell therapy for severe aplastic anemia drives forward cell therapy development and manufacturing innovation.

Priority review, RMAT, and breakthrough status were key regulatory actions intensely accelerating advanced next-gen therapy development in 2025.