Quality Systems

Feliza Mirasol is the science editor for 

Articles

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

FDA Issues Warning Letter to Aspen Biopharma Labs for API Manufacturing Deviations

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.

CARBOGEN AMCIS Receives GMP Certification Following Successful ANSM Inspection

Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.

FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy

The EU medicines agencies’ network strategy, EMANS, is an update of the five-year strategy previously developed to cover the period 2021 to 2025.

EMA and HMA Publish Joint Network Strategy to 2028

Rivaroxaban, long known under the brand name Xarelto, is an anticoagulant, a classification that is among the most-prescribed medications in the United States.

FDA Approves First Generics of Rivaroxaban Tablets

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments, in an interview with Pharmaceutical Technology®.

Industry Outlook 2025: US Political Motivations and Legislative Discussions

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

FDA Makes Class-Wide Labeling Changes to Testosterone Products

In an interview with Pharmaceutical Technology®, Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.

Industry Outlook 2025: Consolidating Data and Relaxing Regulations on AI

CHMP gave its opinion and a recommendation for marketing authorization to Fabhalta (iptacopan), an oral, Factor B inhibitor of the alternative complement pathway.

Novartis Treatment for C3G Gets Positive Opinion from EMA

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Regulatory Oversight and Compliance