Topic

Articles

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue. 

European Pharmacopoeia Goes Digital

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.

Six Biosimilars Part of EMA’s Authorization Recommendations in June

Nishant B. Thakar, RPh, PharmD is assistant professor Clinical Sciences, Roosevelt University College of Science, Health, and Pharmacy.

 is clinical laboratory instructor, University of Illinois College of Pharmacy in Chicago, IL, USA.

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

NIBRT, Firefinch, and eg technology will join the center, adding to its collective of healthcare innovators.

EIT Health Ireland–UK Expands European Network with Three New Members

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

BASF Opens GMP Manufacturing Facility in Michigan

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.

FDA Voucher Program Provides Shorter Drug Application Review Time

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

FDA Posts Slate of Seven Warning Letters Following Company Inspections

NMPA’s Center for Drug Evaluation accepted Merck KGaA’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with TGCTs that require systemic treatment.

China’s NMPA Approves Merck KGaA Treatment for Tenosynovial Giant Cell Tumor

Richard Easton, PhD, is Technical Director–Structural Analysis, BioPharmaSpec Ltd,

Christopher Ziegenfuss is Vice President, at BioPharmaSpec, Inc

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products. 

ICH Q6B for Analytics

The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.

Quality Systems