
EU regulators clear Otsuka’s antisense injectable to prevent hereditary angioedema attacks, reinforcing momentum for RNA-based rare disease medicines.

EU regulators clear Otsuka’s antisense injectable to prevent hereditary angioedema attacks, reinforcing momentum for RNA-based rare disease medicines.

Next-gen antibody R&D is shifting to multifunctional modalities driven by manufacturing scale and regulatory acceleration.

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

A comparison of 2024 and 2025 bio/pharma employment survey results indicates that industry professionals face eroding security, polarized satisfaction, and rising attrition risk.

As adenovirus vectors continue to evolve into versatile platforms for vaccines and complex therapeutics, advances in vector design and formulation are proving critical to ensuring manufacturing consistency, therapeutic potency, and patient-ready delivery at scale.

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.

The company composed a letter addressed to global governments to harness competitiveness and innovation to navigate the current global trade economy.

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.

The partnership boosts BOT+BAL immunotherapy, securing US biologics manufacturing and accelerating Phase III mCRC development globally.

A new FDA draft guidance signals broader acceptance of Bayesian methods, shaping clinical trial design, efficiency, and regulatory strategy in drug development.

Ben Edwards of Avance Clinical explains how generative AI and adaptive trials speed early-stage drug development by improving data access and capital efficiency.

As the J.P. Morgan Healthcare Conference gets underway, Lonza’s Michael De Marco weighs in on regional manufacturing shifts as biotech pipelines mature, signaling new therapy launches within 12–18 months.

Johnson & Johnson reinforces its long-term domestic investment strategy with a new $2 billion biologics facility in Wilson, North Carolina, further elevating the state’s role as a global life sciences hub.

In part two of an interview, Daniel Delubac, iOrganBio CEO, explains how digitized, in-vitro human biology models aim to improve preclinical drug testing.

AI-driven human cell models aim to replace animal testing and deliver more accurate, data-driven insights, says iOrganBio CEO Daniel Delubac ahead of the J.P. Morgan Healthcare Conference.

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.

Single-use technologies provide efficiency and flexibility while reducing risk in the manufacture of cell and gene therapies.

Digitalization is expected to reshape bioprocessing, supply chains, and quality systems for biopharma developers amid tariffs, geopolitics, and shifting capital flows, according to BioPlan Associates’ Eric Langer.

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 hopes the rebranding effort will better align with its work in cell culture media manufacturing.

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

In the final part of an interview with Petra Dieterich and Jeffrey Mocny of Abzena, the current tariff situation in the United States and beyond is considered.

Biomanufacturing is shifting toward more resilient and digitized networks for enhanced supply security amid global and supply-chain volatility.

In the biopharma industry during 2025, quality, tariffs, MFN pricing, and strategic outsourcing deals drove innovation and investment.

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

The complications of conjugate molecules, such as oligonucleotides, are explored in this second portion of an interview with Abzena experts.

Our top 10 videos of the year cover AI, innovation, compliance, and sustainability in biopharma.