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MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies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

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...
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...

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...

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,...

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