USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation
Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a...
Europe – EMA medical terms simplifier
This compilation gives plain-language descriptions of medical terms commonly used in information about medicines. Communication specialists at EMA use these descriptions for materials prepared...
International – Pfizer/BioNTech vaccine effective against Omicron in children five and under
According to recent clinical trial results from Pfizer and BioNTech, a third COVID-19 vaccine dose was well tolerated by children aged five and below,...
Europe – Addendum to the guideline on the evaluation of medicinal products indicated for...
This addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to...
Europe – Guideline on the evaluation of medicinal products indicated for treatment of bacterial...
This Guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for treatment of...
Europe – EMA guidance supports development of new antibiotics
As part of its efforts to support a global approach to the development of new antimicrobial medicines, EMA has published the final revised guideline on the...
USA – Les Etats-Unis se dirigent vers la vaccination des cas contacts contre la...
Les Etats-Unis se préparent à vacciner les personnes ayant été en contact proche avec des patients atteints de la variole du singe, au moment...
UK – G7 health ministers unite to protect world from another pandemic
Commitments also made on tackling antimicrobial resistance (AMR) – a global killer costing millions of lives a year
Focus on climate and health...
USA – FDA asks manufacturers to develop risk management plans to avert shortages
The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...
Europe – First therapy to treat two types of Niemann-Pick disease, a rare genetic...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Xenpozyme (olipudase alfa), a therapy for the treatment of non-central nervous system (CNS)...
