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...
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...
UK – Merck’s Keytruda recommended by NICE to reduce risk of lung cancer recurrence
The anti-PD-1 therapy has been specifically recommended for use in combination with platinum-based chemotherapy as a neoadjuvant treatment before surgery and then as a...
USA – FDA drafts guidance on drug interaction labeling
The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug...
UK – Roche’s Alecensa receives NICE recommendation to treat ALK-positive lung cancer
The drug has been specifically recommended by the health technology assessment agency as an adjuvant treatment for adults with stage 1B to 3A ALK-positive...
