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fast track designation

- PMLiVE

US FDA approves Taiho’s Inqovi for older adults with acute myeloid leukaemia

In 2026, an estimated 22,720 people in the US will be diagnosed with AML

- PMLiVE

J&J’s Icotyde approved by US FDA for plaque psoriasis

Plaque psoriasis affects over 125 million people worldwide

- PMLiVE

Lilly’s Foundayo approved by US FDA as oral GLP-1 for weight loss

Taken at any time of the day, the oral GLP-1 is the only pill to have no food or water restrictions

- PMLiVE

J&J’s nipocalimab gets FDA Fast Track designation for lupus

The autoimmune disease affects approximately three to five million people globally

- PMLiVE

Johnson & Johnson’s Darzalex Faspro regimen receives FDA approval for multiple myeloma

Multiple myeloma has an average five-year survival rate of 59.8% and is currently incurable

- PMLiVE

Biogen’s litifilimab receives FDA Breakthrough Therapy Designation for lupus

Therapies like topical steroids manage symptoms but there is currently no cure

- PMLiVE

Johnson & Johnson’s Rybrevant shows positive effects in difficult-to-treat colorectal cancer

Colorectal cancer accounts for around 10% of all cancer cases globally, with an increase in diagnoses in younger people

- PMLiVE

AstraZeneca’s Saphnelo demonstrates positive results in systemic lupus erythematosus

Over 3.4 million people globally are affected by SLE, and it is one of the leading causes of death in young women in the US

- PMLiVE

J&J receives positive NICE recommendation for multiple myeloma treatment

The treatment is approved for use within the NHS in England and Wales

- 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

Johnson & Johnson seeks first EMA approval for icotrokinra for plaque psoriasis

Icotrokinra is a first-in-class, once-daily tablet for moderate-to-severe plaque psoriasis

- PMLiVE

John Morikis joins Johnson & Johnson’s board of directors

Morikis was previously Chairman, President and CEO at Sherwin-Williams

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