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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

Pfizer’s Hympavzi significantly reduces bleeds in haemophilia patients

Over 800,000 people worldwide live with haemophilia

- 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

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

Cladribine capsules could become the first ever oral treatment for gMG

- PMLiVE

Pfizer’s PADCEV gets FDA approval for bladder cancer

Bladder cancer affects more than 614,000 people globally each year

- 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

Pfizer and Metsera agree on merger after bidding war between Pfizer and Novo Nordisk

The Pfizer bid was chosen by Metsera after a concern was raised about US antitrust laws regarding the Novo Nordisk offer

- 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

Pfizer’s Lorviqua recommended by NICE for lung cancer

Lung cancer is the leading cause of cancer-related deaths worldwide

- 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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