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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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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

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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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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

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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

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GSK creates new consumer healthcare business, Haleon

Haleon, whose brand portfolio will include Sensodyne toothpaste and Panadol painkillers, is the combination of the consumer health businesses of GSK and Pfizer

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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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Roche’s Lunsumio granted Priority Review by FDA for people with relapsed or refractory follicular lymphoma

If approved, this could be the first such antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma

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Pfizer’s Paxlovid given FDA permission to be prescribed by US pharmacists

Under the Emergency Use Authorisation revision, pharmacists will be able to prescribe the COVID-19 treatment to patients, providing they meet certain conditions

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FDA grants Priority Review for Biogen and Eisai’s lecanemab for early Alzheimer’s disease

Lecanmab is being evaluated in the ongoing phase 3 Clarity Alzheimer's clinical trial

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