AstraZeneca’s Enhertu combination approved by FDA for HER2-positive breast cancer
Around one in five breast cancer cases are HER2-positive
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Section: Regulatory
FDA approves first gene therapy for Wiskott-Aldrich syndrome
Symptoms of the rare disease include bleeding, eczema and frequent infections
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Global regulatory standards
The US, EU and UK operate under different systems, with distinct expectations for clinical evidence, timelines and commercial readiness
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Roche receives FDA clearance for whooping cough test
There are around 24.1 million cases of whooping cough annually, with around 170,000 deaths
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AstraZeneca’s Imfinzi receives FDA approval for gastric and gastro-oesophageal cancers
In 2022, nearly one million new patients were diagnosed with gastric cancer
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