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Gilead claims first FDA nod for a hepatitis D therapy
At its second attempt, Gilead has won FDA approval for chronic hepatitis D virus drug Hepcludex, four years after it was cleared in the EU.
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Oral Wegovy backed by CHMP at May meeting
The CHMP recommended eight new medicines and 13 line extensions at its May meeting, including Novo Nordisk's oral weight loss therapy.
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NICE changes stance on Genmab's cervical cancer drug
After saying it couldn't recommend Genmab's cervical cancer therapy Tivdak for use by the NHS, reimbursement authority NICE has had a change of heart.
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Bayer gets swift review for Kerendia in type 1 diabetes
FDA starts a priority review of Bayer's Kerendia for chronic kidney disease in type 1 diabetes, which could end a 30-year drought in new therapies.
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European study shows inequality in access to new medicines
Trade organisation EFPIA says disparities in access to new medicines in Europe may be exacerbated by the US's Most-Favoured Nation (MFN) policy.
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