North Carolina Governor Josh Stein announced that pharmaceutical giant Johnson & Johnson (J&J) will expand its presence in ...

Last week, biotechnology company Ascidian Therapeutics announced a manufacturing partnership with gene-therapy–focused ...

The Priority Review Voucher (PRV) program is designed to incentivize rare disease drug development.

Meanwhile, Novotech has appointed Anand Tharmaratnam as its own new CEO. Tharmaratnam has over 30 years of industry ...

Stéphane Bancel, CEO of vaccine maker Moderna, addressed shareholders in a letter that dissected the events of 2025 while ...

But cell and gene therapies (CGTs) are catching up. During Cell and Gene Therapy International Europe 2025, held in Berlin, ...

Contract development and manufacturing organization (CDMO) Rentschler Biopharma has announced a partnership with ...

Contract development and manufacturing organization (CDMO) Samsung Biologics made a splash at the end of 2025, acquiring ...

The biopharmaceutical industry is at the forefront of technological advancements, with “biopharma 4.0” revolutionizing the way biomanufacturing is conducted (1). The concept combines automation, ...

Figure 1A: Antibody–drug conjugate (ADC) structure and delivery pathways; linker chemistry determines the mechanism by which cytotoxin release occurs. This schematic shows a monoclonal antibody (MAb) ...

Effectively managing deviations is fundamental to ensuring product quality, regulatory compliance, and patient safety. Intricate processes are involved in deviation management, from the initiation ...