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- PMLiVE

FDA approves first gene therapy for Wiskott-Aldrich syndrome

Symptoms of the rare disease include bleeding, eczema and frequent infections

- PMLiVE

FDA launches TEMPO digital health pilot

Digital technologies can improve remote patient care for those with chronic diseases

- PMLiVE

Roche’s Columvi improves survival in large B-cell lymphoma

Approximately 160,000 people are diagnosed with this aggressive form of cancer each year

- PMLiVE

Roche receives FDA clearance for whooping cough test

There are around 24.1 million cases of whooping cough annually, with around 170,000 deaths

- PMLiVE

Richard Pazdur, FDA’s drug evaluation chief, to leave FDA just weeks into new role

Pazdur was previously head of the FDA’s Oncology Center of Excellence

- PMLiVE

Regeneron’s Libtayo receives EC approval for skin cancer

Phase 3 trial results showed the drug significantly improved disease-free survival

- PMLiVE

Merck KGaA given FDA Fast Track designation for generalised myasthenia gravis drug

Cladribine capsules could become the first ever oral treatment for gMG

- PMLiVE

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

- PMLiVE

Genentech announces positive clinical results for BTK inhibitor MS treatment

Multiple sclerosis affects more than 2.9 million people globally

- PMLiVE

GSK’s Blenrep approved by FDA for multiple myeloma

Approval supported by positive results from phase 3 trial

- PMLiVE

MHRA and FDA expand collaboration on AI and medtech regulation

National Commission on the Regulation of AI in Healthcare brings together UK and US experts

- PMLiVE

Roche’s small cell lung cancer therapy approved by FDA

This is the first and only approved combination therapy for extensive-stage small cell lung cancer

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