International – Mpox : l’OMS approuve un second vaccin, fabriqué par une société pharmaceutique...

Un nouveau vaccin contre la mpox, fabriqué par la société pharmaceutique japonaise KM Biologics pour un usage d’urgence, a été approuvé, mardi 19 novembre, par...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Sparsentan approved to treat adult patients with primary immunoglobulin A nephropathy (IgAN)

IgA neuropathy, also known as Berger’s disease, is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in your...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2024 meeting. The committee recommended granting a conditional...

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...
NHS prepares to fast-track ‘game changing’ cancer drugs that target genetic mutations

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,...
Intracranial Hemorrhage Detection Software Receives FDA Clearance

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...