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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

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

Novartis’ Itvisma gets FDA approval for spinal muscular atrophy treatment

Around 9,000 people in the US currently live with SMA

- PMLiVE

Novartis announces plans for new US manufacturing hub

The US hub is expected to create 700 new jobs by 2030

- 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

Novartis reports primary endpoint reached in phase 3 malaria trial

The treatment demonstrated non-inferiority to current standard of care

- 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

GSK’s Blenrep approved by FDA for multiple myeloma

Approval supported by positive results from phase 3 trial

- PMLiVE

Novartis presents new positive data for rheumatic autoimmune disease treatment

Patient outcome benefits were observed in two ongoing phase 3 trials

- PMLiVE

Novartis to acquire Avidity Biosciences in deal worth $12bn

The acquisition will expand Novartis’ neuroscience pipeline

- 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

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