Quality/GMPs

FDA’s IND clearance advances CStone’s trispecific antibody into Phase II development, expanding multispecific immunotherapy in solid tumors.

FDA’s acceptance of Precision BioSciences’ IND advances ARCUS gene excision toward clinical validation, signaling progress for durable DMD therapies.

Akeso’s bispecific antibody gains momentum on the NMPA’s designation, while Phase III data advance a new first-line option for advanced biliary tract cancer.

PharmaResearch’s DOT-based nanoparticle platform enters US clinical testing, highlighting delivery innovation aimed at improving tolerability in solid tumor therapies.

FDA’s acceptance of Affinia Therapeutics’ IND positions the company to test lower-dose, heart-targeted AAV gene therapy for BAG3 cardiomyopathy.

Regulatory review of Eisai’s subcutaneous lecanemab highlights how delivery innovation may expand access and scalability for disease-modifying Alzheimer’s therapies.

This fast track designation signals growing regulatory momentum for trispecific antibodies as the myeloma field pushes beyond single-target immunotherapies.

The European Commission’s approval of GSK’s Arexvy for adults 18 years and older expands the respiratory syncytial virus vaccine market and signals broader adoption of adult immunization strategies.

Green chemistry is emerging as a strategic lever for biopharma manufacturing, enabling safer processes, efficiency gains, and long-term competitiveness.

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

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 development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

A new FDA draft guidance signals broader acceptance of Bayesian methods, shaping clinical trial design, efficiency, and regulatory strategy in drug development.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

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.

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

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.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets.

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

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

FDA leadership initiated rapid drug review programs, enhanced transparency by publishing decision letters in real time, and strategically integrated AI into agency operations.

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.