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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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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

regeneron headquarters

Regeneron and Intellia to develop additional gene editing therapies under expanded collaboration

The companies will develop CRISPR-based therapies for neurological and muscular diseases

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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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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Sandoz’s Tyruko approved by FDA as first biosimilar for relapsing multiple sclerosis

The disease-modifying therapy is approved to treat all indications covered by Tysabri

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Pfizer and Astellas’ Xtandi granted FDA priority review for new prostate cancer indication

The treatment is already approved in the US for three disease states of prostate cancer

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Pfizer’s maternal RSV vaccine granted FDA approval to protect infants

The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy

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