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- PMLiVE

Roche’s Xofluza issued FDA approval to treat influenza in children aged five years and older

It is the first and only single-dose oral medicine for this indication in children as young as five

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Sanofi halts recruitment for trials assessing MS treatment

The pause in enrolment follows advice issued by the Independent Data Monitoring Committee

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FDA approves Bot Image’s AI software for the detection and diagnosis of prostate cancer

ProstateID combines artificial intelligence with traditional MRI scanning to significantly improve radiologic interpretation accuracy

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AstraZeneca and Daiichi Sankyo get FDA approval for breast cancer drug

Results from a phase 3 trial showed Enhertu reduced the risk of disease progression or death by 50%

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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

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Arcutis receives FDA approval for steroid-free plaque psoriasis treatment

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

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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

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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

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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

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FDA approves Incyte’s Opzelura for vitiligo

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

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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

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