Development

Articles

Advancing preclinical research with virtual control groups

The future of non-clinical research may depend on integrating VCGs for a more humane and efficient approach.

Notable 2024 FDA decisions

A look at consequential drug approvals and rejections from this year

Pharma’s molecular glue garden

With key players entering the ring and many clinical trials underway, the molecular glue garden is bound to bloom soon

Batch process understanding for process validation and quality control

A first-of-its-kind study of isotopic values of paired reactants and products offers a prospective new method of process understanding

Strengthening pharma’s sustainability foundation

New tools can help seamlessly integrate sustainability into R&D and production goals

News

FDA hands Biohaven refusal to file letter

AZ, Sanofi closing in on first approval for RSV in 23 years

Novo teams with Aspect on bioprinted diabetes treatments

FDA approves BMS psoriasis TYK2 inhibitor

Fresenius Kabi snags its first biosimilar approval

Bridge Bio, Brainomix partner to use AI in lung fibrosis trial

Vaccines of the future

There is a new era of vaccinology in pharma's pipelines

Excipient-based strategies to harness complex therapeutics

Though excipients are a necessary drug component that can often be taken for granted, the ever-changing pharma landscape is always pushing us to shift our perspectives.

Bringing down the barriers to process monitoring in biopharma

How modern process analytical technologies such as Raman spectroscopy can improve quality control

Bridging the gap between R&D and GMP

Companies prioritizing optimized synthetic routes, stable API forms, and verified analytical tools set the stage for phase I clinical manufacturing success