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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…
AbbVie’s Rinvoq® will be the first JAK inhibitor available for treatment of Crohn’s in England and Wales, following NICE approval.
EMA’s human medicines committee had cleared the cannabidiol oral solution, Epidiolex, for use to treat seizures.
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.
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
New supercomputing centres have been selected to support Europe's researchers, industry and businesses to design medicines.
The FDA has given its approval to a new injection for cluster headaches which reduce frequency of attacks.
The pharmacovigilance of new drugs and drug formulations undertaken in New Zealand should be proactive, says a leading expert.
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...
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...
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
Bayer have announced the European Commission has granted marketing authorisation for Stivarga...
