Europe – Leqembi recommended for treatment of early Alzheimer’s disease
After re-examining its initial opinion, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation to Leqembi (lecanemab) for treating mild cognitive impairment...
USA – FDA proposes removing oral phenylephrine from use in nasal decongestants
The US Food and Drug Administration (FDA) announced on Thursday plans to remove oral phenylephrine from the over-the-counter (OTC) monograph for nasal decongestants following...
UK – NHS rolls out ‘stop-smoking’ pill to help tens of thousands quit
Varenicline has been shown to work as well as vapes to help people stop smoking and be a more effective aid than nicotine-replacement gum...
UK – NICE recommends Blueprint Medicines’ Ayvakyt to treat rare blood disorder
The drug can now be used as a monotherapy to treat patients in England and Wales with the three subtypes of advanced SM: aggressive...
UK – NICE recommends remote monitoring technology for heart failure patients
The National Institute for Health and Care Excellence (NICE) has announced that people with heart failure can now stay healthier remotely through advanced remote...
France – Mettre à disposition les informations et données autour du médicament aux patients...
Chaque année en France, environ 130 000 personnes sont hospitalisées suite à des effets indésirables suspectés d’être dus à un mauvais usage des médicaments,...
UK – Pfizer’s Elrexfio recommended by NICE to treat relapsed and refractory multiple myeloma
The BCMA-directed bispecific antibody will now be available for use on the NHS in England via the Cancer Drugs Fund (CDF) while more evidence...
Europe – EMA proposes updated guideline on peripheral arterial occlusive disease treatments
The European Medicines Agency (EMA) on Thursday released a draft guideline on developing drugs to treat peripheral arterial occlusive disease (PAOD) of the lower...
USA – FDA revises more than 800 PSGs in line with ICH M13A
The US Food and Drug Administration (FDA) on Thursday published revised draft product-specific guidances (PSGs) for immediate-release solid oral generic drugs deemed to be...
UK – NICE recommendation for new Alexion PNH treatment
Alexion, AstraZeneca Rare Disease, announced that the National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Voydeya (danicopan).
This first-in-class,...
