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FDA establishes new advisory committee to provide expertise on digital health

The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds

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Pfizer announces FDA approval for Braftovi/Mektovi combination in lung cancer

Non-small cell lung cancer accounts for approximately 85% of all lung cancers cases

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Novavax’s updated COVID-19 vaccine approved by FDA for emergency use

Individuals aged 12 years and older will be eligible to receive the company's updated vaccine

Biogen Idec building

Biogen’s Actemra biosimilar approved by FDA to treat adult and paediatric arthritis

Tofidence is now the first biosimilar referencing Actemra to gain approval from the US regulator

regeneron headquarters

Regeneron’s odronextamab granted FDA priority review for non-Hodgkin lymphoma

The regulator is expected to make a decision on the drug by the end of March 2024

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Pfizer’s Abrysvo RSV vaccine recommended by US CDC for infants

The recommendation allows Abrysvo to be given to pregnant women from 32 to 36 weeks

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Pfizer’s Litfulo approved by EC for adults and adolescents with severe alopecia areata

The autoimmune disease affects approximately 147 million people globally

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Date set for EU antitrust regulators to decide on Pfizer’s $43bn Seagen acquisition

The proposed transaction would mark a significant boost to the US pharma’s oncology pipeline

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GSK’s Ojjaara receives FDA approval to treat myelofibrosis patients with anaemia

Myelofibrosis is a rare blood cancer affecting approximately 25,000 patients in the US

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FDA boosts collaboration with manufacturers to overcome ongoing cancer drug shortages

The supply of cisplatin, carboplatin and methotrexate has nearly halved in the past year

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Alnylam’s patisiran backed by FDA advisory committee for ATTR cardiomyopathy

Treatment options for the underdiagnosed and rapidly progressive condition are currently limited

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FDA approves Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines

The vaccines have both been adapted to target the currently circulating XBB.1.5 Omicron variant

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