regulatory

Market Access

The global pharmaceutical landscape is increasingly defined by the necessity for clinical acceleration without compromising data integrity.

News

The FDA has started a priority review of Sanofi's brain-acting Gaucher disease therapy venglustat, with an action date of 25th November.

News

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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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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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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LSE pharma policy expert contends the MHRA/NICE aligned pathway is weighted towards industry, and calls for an assessment of its impact on the NHS.