US efforts to scrutinise overseas drug manufacturing could expose Europe’s role in supplying FDA-approved innovator and biosimilar drugs.

Resilience and Lilly have invested $750m to boost production of Lilly’s KwikPen to boost the US supply of diabetes and obesity medicines.

Cell and gene therapy manufacturers are partnering with specialist technology companies to address the challenges associated with scaling complex therapies.

AbbVie's Rinvoq, Pfizer and BioNTech's Comirnaty and Incyte's Opzelura have all received their own EU drug regulatory approvals this week.

Synlogic and Caldera Therapeutics have signed a definitive merger agreement aimed at combining in an all-stock transaction.

Amgen has received a positive opinion from the EMA’s CHMP for Repatha supporting its broader use prior to a first heart attack or stroke.

Specialised Therapeutics’ Niktimvo (axatilimab) was registered in the Australian Register of Therapeutic Goods for later-line cGVHD.

Researchers estimate that pharma could unlock up to $1.2tn in commercial value from tropical forests by supporting biodiversity conservation.

Committee members voted 9-3 against recommending approval of Capricor’s deramiocel. Credit: Andrii Yalanskyi/Shutterstock.com. A US Food and Drug Administration (FDA) advisory committee meeting (AdCom ...

Despite shifts in key compliance frameworks and ongoing digitalisation across the entire pharmaceutical value chain, many organisations still rely on paper-based legacy systems and siloed compliance ...

GSK will reallocate a large portion of the £1.9bn saved through to 2029 towards late-stage pipeline acceleration, primarily in oncology.

Eisai has entered an exclusive global licensing agreement with CORE Biomedicine for several preclinical oncology programmes.