FDA delays verdict on AZ breast cancer drug
After an advisory committee setback, AstraZeneca has a chance to make the case for its oral SERD camizestrant for breast cancer.
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After an advisory committee setback, AstraZeneca has a chance to make the case for its oral SERD camizestrant for breast cancer.
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.
The CHMP recommended eight new medicines and 13 line extensions at its May meeting, including Novo Nordisk's oral weight loss therapy.
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.
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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