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Bayer’s Nubeqa receives FDA approval to treat metastatic prostate cancer

The risk of death was reduced by 32% by adding the drug to standard therapy

- PMLiVE

Janssen’s Stelara approved by FDA for psoriatic arthritis in paediatric patients

Active psoriatic arthritis affects 5-8% of children and adolescents with chronic inflammatory arthritis

- PMLiVE

Arcutis receives FDA approval for steroid-free plaque psoriasis treatment

Zoryve is the first and only PDE4 inhibitor approved for plaque psoriasis

- PMLiVE

Sarepta to submit application for Duchenne muscular dystrophy gene therapy

The condition occurs in approximately one in every 3,500-5,000 newborn males worldwide

- PMLiVE

FDA grants priority review to Biogen’s tofersen for genetic form of ALS

The approval follows a failed phase 3 study, but the treatment showed promise in patients with SOD1-ALS

- PMLiVE

Bristol Myers Squibb launches initiative to ensure disability diversity in clinical trials

Current common clinical trial practices exclude up to a quarter of the US population based on disability status

- PMLiVE

Sandoz’s biosimilar medicine application accepted by FDA

If approved, the higher concentration formulation could decrease the number of injections required for patients currently receiving a lower dose of Hyrimoz

- PMLiVE

FDA approves Incyte’s Opzelura for vitiligo

It is the first and only FDA-approved product for repigmentation in patients with nonsegmental vitiligo

- PMLiVE

Roche’s diagnostic test for Alzheimer’s receives FDA Breakthrough Device Designation

Alzheimer's affects more than 55 million people globally and is the most common form of dementia

- PMLiVE

Bristol Myers Squibb announces NICE recommendation for Opdivo plus Yervoy to treat unresectable malignant pleural mesothelioma

The treatment combination is the first immunotherapy of its kind in over ten years to be made available via the NHS

- PMLiVE

FDA grants Novavax’s COVID-19 vaccine emergency use authorisation for adults

The decision was based on data from a phase 3 trial which showed the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19

- PMLiVE

Bristol Myers Squibb’s Opdivo given NICE recommendation for urothelial cancer treatment

The treatment will be available on the NHS as an adjuvant treatment for those at high-risk of recurrence

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