news
FDA approves first drug to treat common form of dwarfism in children
The US Food and Drug Administration (FDA) approves vosoritide injection to improve growth in children at least five years of age with achondroplasia and open epiphyses.
List view / Grid view
Regulation & Legislation
whitepaper
User guide: Calibration and adjustment of dispensing systems
User guide for the calibration of pipettes and dispensers in the laboratory.
news
NICE approves first long-acting injectable HIV-1 treatment
NICE has published draft guidance recommending cabotegravir, the first long-acting injectable treatment for HIV-1 infection in adults.
news
European Commission grants marketing authorisation for Vumerity®
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
news
NICE does not recommend elosulfase alfa for Morquio A syndrome
The new draft guidance does not recommend Vimizin (elosulfase alfa) for the treatment of Morquio A syndrome following new evidence.
news
FDA approves Besremi to treat rare blood disease
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera.
news
EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
whitepaper
Application note: Impurity analysis of gabapentin by HPLC-UV-CAD
This application aims to replace the two separate compendial methods for the impurity analysis of gabapentin with one single HPLC method.
video
On-demand webinar: Water systems – microbial monitoring
This webinar considers the fundamental importance of water system control within pharma processing and the best control and monitoring practices.
whitepaper
Whitepaper: Impact of a pandemic outbreak on vaccine development approach
This whitepaper explores vaccine development during a pandemic, a response to complex challenges that traditional manufacturing methods will not solve.
news
NICE recommend dapagliflozin for treating chronic kidney disease
The new draft guidance has recommended dapagliflozin as an option for treating certain people with chronic kidney disease (CKD) in adults.
article
Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
whitepaper
Press release: Telstar: 360 degrees GMP consultancy & engineering solutions at CPhI
Telstar promotes innovative aseptic production solutions in a setting marked by the new GMP Annex 1.
whitepaper
Toolkit: Nitrosamine analysis workflows
Everything you need to have confidence and compliance in your nitrosamine impurity analysis.
article
Maintaining EU MDR certification: a spotlight on post‑market clinical follow-up
Celeste Maksim, Chief of Staff, Clinical and Post-Market Practice, RQM+ advises on strategising for PMCF compliance, highlighting areas to prioritise to ensure an efficient process.
