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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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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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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Eisai submits new drug application for subcutaneous Leqembi in Japan
LEQEMBI is a treatment for early Alzheimer’s disease
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Novartis’ Itvisma gets FDA approval for spinal muscular atrophy treatment
Around 9,000 people in the US currently live with SMA
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Regeneron’s Libtayo receives EC approval for skin cancer
Phase 3 trial results showed the drug significantly improved disease-free survival
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Sandoz launches first and only multiple sclerosis biosimilar in US
The treatment is FDA-approved to treat MS and Crohn’s disease
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J&J receives positive NICE recommendation for multiple myeloma treatment
The treatment is approved for use within the NHS in England and Wales
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Biogen and Eisai receive MHRA approval for updated dosing of early Alzheimer’s treatment
The MHRA approval for IV dosing comes following positive results from the global phase 3 trial
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Merck ends development agreement with Dr Falk Pharma for monoclonal antibody
Merck will take full control of developing MK-8690, an investigational monoclonal antibody candidate
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Johnson & Jonson secures FDA approval for multiple myeloma treatment
Support for first and only high-risk smouldering multiple myeloma treatment came from positive phase 3 trial results
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