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Orgovyx

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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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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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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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Pfizer and BioNTech sign $3.2bn COVID-19 vaccine supply agreement with US government

The companies will supply 105 million doses, which may include adult Omicron-adapted COVID-19 vaccines, subject to FDA authorisation

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FDA issues innovative proposal to increase nonprescription drug access

Nonprescription drugs provide an efficient, low-cost way to manage everyday health needs and include drugs for allergies, pain, fever and many more indications

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