Pharmafile Logo

patent lawsuit

- 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

Sandoz launches first and only multiple sclerosis biosimilar in US

The treatment is FDA-approved to treat MS and Crohn’s disease

- 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

Amgen reports positive results from landmark cardiovascular study

The study found significant reductions of major cardiovascular events in high-risk adults following treatment

- 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

Sandoz to acquire Just-Evotec Biologics to strengthen biosimilar development and manufacturing capabilities

Acquisition will add in-house continuous manufacturing expertise and expand Sandoz’s biosimilar production capacity

- PMLiVE

GSK’s Blenrep approved by FDA for multiple myeloma

Approval supported by positive results from phase 3 trial

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links