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...

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,...

UK – NICE recommends Santen’s Roclanda to treat glaucoma and ocular hypertension

The National Institute for Health and Care Excellence (NICE) has issued guidance recommending Santen’s Roclanda for use in patients with primary open-angle glaucoma (POAG)...

UK – AstraZeneca’s Voydeya recommended by NICE to treat rare blood disorder PNH

The oral factor D inhibitor has been recommended for use alongside AZ’s complement component 5 (C5) inhibitors, Ultomiris (ravulizumab) or Soliris (eculizumab) to treat...

UK – Ipsen’s Iqirvo recommended by NICE to treat rare liver disease primary biliary...

The drug can now be used in combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA, or as a monotherapy...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Eli Lilly’s Alzheimer’s drug Kisunla approved by MHRA but not recommended by...

Kisunla (donanemab-azbt), administered as an intravenous infusion every four weeks, has been approved by the UK regulator to treat mild cognitive impairment and mild...