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CHMP meeting highlights – May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
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European Commission
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New EU guidance seeks to address radiopharmaceutical supply chain vulnerabilities
The recommendations are issued amid increasing pressure on the complex supply chain for radiopharmaceuticals, medicines which are used to treat conditions such as cancer.
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Botanical drugs – what is the best way forward for regulatory and market approval?
Botanical drugs, also known as traditional herbal therapies, have long been used, but obtaining regulatory approval for these medicines, or therapies, is convoluted. Often manufacturers will market their botanical drugs as dietary supplements or traditional therapies, designations that require far less regulatory approval than marketisation as a drug. In this…
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NICE recommends Rinvoq® for Crohn’s
AbbVie’s Rinvoq® will be the first JAK inhibitor available for treatment of Crohn’s in England and Wales, following NICE approval.
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Cannabidiol-based treatment receives marketing approval from EMA
EMA’s human medicines committee had cleared the cannabidiol oral solution, Epidiolex, for use to treat seizures.
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EMA recommends Vitrakvi for EU marketing authorisation
The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.
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US and EU enter Mutual Recognition Agreement for drug manufacturing inspections
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
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European supercomputers to aid in medicine development
New supercomputing centres have been selected to support Europe's researchers, industry and businesses to design medicines.
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First treatment for cluster headaches approved in US
The FDA has given its approval to a new injection for cluster headaches which reduce frequency of attacks.
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Pharmacovigilance of new drugs ‘should be more proactive’ in New Zealand
The pharmacovigilance of new drugs and drug formulations undertaken in New Zealand should be proactive, says a leading expert.
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EMA grants marketing authorisation for subcutaneous formulation of Benlysta against lupus
The EU has approved a new subcutaneous formulation of Benlysta, as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus...
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EC grants marketing authorisation of Dupixent for atopic dermatitis
Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the EC has granted marketing authorisation for Dupixent for use in adults with moderate-to-severe atopic dermatitis...
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Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
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Bayer receives EU approval for Regorafenib
Bayer have announced the European Commission has granted marketing authorisation for Stivarga...
