Some observers see risks to becoming over-reliant on local facilities, noting the potential need for trade partners if ...

CDER Director George Tidmarsh said on two separate events last week that he thought advisory committee meetings for specific ...

The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing.

Jane Koo, PhD, head of regulatory at CTMC, is a regulatory expert with 20 years of experience in biologics and advanced therapies.

AstraZeneca in January also stopped its $610 million plans to construct a vaccine R&D and manufacturing site in the U.K.

A depleter of pathogenic T cells, rosnilimab’s novel MOA generated a differentiated efficacy, tolerability and safety profile ...

While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this ...

After decades without much movement, a handful of new treatments for this rare autoimmune disease are now approved, and ...

On the FDA’s docket for the back half of September is Merck’s proposed subcutaneous formulation of its blockbuster cancer drug Keytruda.

Analysts at BMO Capital Markets expect the lack of other exon-44-skiping therapies to facilitate a "smooth" approval process ...

LB Pharma has finally done it. The biotech IPO stalemate has been broken, with the neuroscience-focused company landing on ...

The autoimmune and inflammatory disease–focused company canceled plans to go public earlier this year as the IPO window ...