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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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Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine approved by MHRA

The updated vaccine proved effective against the currently circulating XBB.1.5 subvariant

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Seagen and Genmab’s Tivdak shows promise in phase 3 cervical cancer trial

The drug received FDA accelerated approval in 2021 to treat patients with advanced disease

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Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine approved by EC

The vaccine is approved for use in adults, children and infants over six months

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Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine recommended by CHMP

Doses will be ready to ship immediately upon authorisation by the European Commission

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Pfizer’s RSV vaccine granted EC approval to protect infants and older adults

The decision allows Abrysvo to be given to those who are 24 to 36 weeks into their pregnancy

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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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Regeneron’s Veopoz granted FDA approval for ultra-rare immune disease

Fewer than ten patients in the US have been diagnosed with CHAPLE disease

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Ipsen’s Sohonos gets FDA approval for fibrodysplasia ossificans progressive

The drug is the first-ever treatment approved in the US for patients with the disease

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Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

The therapy showed an overall response rate of more than 70% in a broad range of patients

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