USA – FDA approves new Alzheimer’s treatment regimen
The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once every four weeks intravenous (IV) maintenance...
Europe – European Shortages Monitoring Platform fully operational for monitoring of shortages in the...
The European Shortages Monitoring Platform (ESMP) is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and national competent authorities (NCAs) to...
Europe – New combination of medicines to treat parasitic worm infections
EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Ivermectin/Albendazole for the treatment of infections caused by several types of worm...
International – Health agencies recommend best practices for using surrogate endpoints
A consortium of health technology assessment (HTA) agencies has released a white paper that aims to help pharmaceutical manufacturers provide better data on using...
USA – CDER announces new guidance agenda for 2025
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released a new guidance agenda detailing the new and revised guidance...
UK – AstraZeneca receives NICE recommendations for lung cancer drugs Tagrisso and Imfinzi
Tagrisso has been recommended for use as an adjuvant treatment following complete resection in adults with stage 1B to 3A non-small cell lung cancer...
Europe – European Pharmacopoeia Commission adopts first three general texts on mRNA vaccines
At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) adopted three new general texts relating to the production and quality control of...
USA – FDA draft guidance outlines appropriate use of tissue biopsies in clinical trials
When are tissue biopsies really needed in clinical trials of medical products? Draft guidance from the US Food and Drug Administration (FDA) offers recommendations...
International – WHO guideline aims to facilitate the development of “more durable” pediatric medicines
The World Health Organization (WHO) has released a draft guideline to encourage the development of better-formulated and higher-quality pediatric medicines. The guideline targets member...
USA – FDA proposes to modernize guidance on sex, gender in clinical trials
The US Food and Drug Administration (FDA) is proposing to update two guidance documents that clarify terminology around sex and gender of clinical trial...
