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

Seventeen new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended seventeen medicines for approval at its December 2024 meeting. This brings the total...

Europe – First treatment recommended for rare progressive lung conditions in children and adolescents

EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents from the age of...

UK – NICE endorses Neuraxpharm’s ublituximab for treating MS

Neuraxpharm Group has announced that the National Institute for Health and Care Excellence (NICE) has recommended ublituximab (BRIUMVI®) for the treatment of relapsing-remitting multiple...

UK – NICE recommends Immunocore’s Kimmtrak as first drug for aggressive eye cancer

Kimmtrak will now be available on the NHS in England to treat HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, with more than 100...

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...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies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...
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...

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