Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024
Doxycycline: currently available evidence not supporting link with risk of suicidality
EMA’s safety committee (PRAC) has concluded that the currently available evidence is not sufficient...
USA – FDA recommends collecting ovarian toxicity data in cancer drug trials
The US Food and Drug Administration (FDA) is proposing sponsors collect ovarian toxicity data during cancer drug development. The agency said that cancer drugs...
France – Tramadol et codéine devront être prescrits sur une ordonnance sécurisée
Tramadol et codéine sont des médicaments opioïdes. Les risques de mésusage, de dépendance, d’abus et de surdosage qui leur sont associés sont importants. Afin...
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...
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...
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...
