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Roche gets EU okay for first HER2-low test kit

Roche has obtained a CE Mark in the EU for a companion diagnostic that can be used to identify patients with HER2-low metastatic breast cancer who may be eligible for trea

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UK calls time-out on post-Brexit rules opposed by industry

It has been more than four years since the UK left the EU, but the government is still being forced to delay the introduction of border control rules that could have conse

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Sarah was born with ADA-SCID but was fortunate to access gene therapy via a clinical trial

NHS trust bids to take license for abandoned gene therapy

An NHS trust has taken the pioneering step of applying to hold the marketing authorisation for a gene therapy for a rare disease that was abandoned by a biotech developer

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Study points to weaknesses in FDA accelerated approval path

Less than half of the cancer therapies that were granted accelerated approval by the FDA between 2013 and 2017 showed a clinical benefit in a confirmatory trial within the

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Enhertu gets FDA nod for tumour-agnostic HER2 cancers

The FDA has approved the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu for all HER2-positive solid tumours, in a first for both HER2 inhibitors a

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Carvykti, Abecma move earlier in multiple myeloma treatment

Johnson & Johnson and Legend Biotech’s BCMA-targeted CAR-T therapy Carvykti has been approved by the FDA to treat patients with multiple myeloma after at least one pri

Roche gets EU okay for first HER2-low test kit

UK calls time-out on post-Brexit rules opposed by industry

NHS trust bids to take license for abandoned gene therapy

Study points to weaknesses in FDA accelerated approval path

Enhertu gets FDA nod for tumour-agnostic HER2 cancers

Carvykti, Abecma move earlier in multiple myeloma treatment

Ipsen' Bylvay fluffs its lines in biliary atresia trial

Discover a new era of healthcare panel engagement: Grounded ...

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