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Lisocabtagene maraleucel

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FDA completes meeting for potential genetic therapy to treat sickle cell disease

If approved, exa-cel will be the first genetic therapy available to treat patients with severe sickle cell disease

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Novartis’ Cosentyx receives FDA approval for hidradenitis suppurativa

The decision makes Cosentyx the first biologic treatment approved for HS in nearly a decade

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bluebird bio to sell FDA priority review voucher for $103m

The company previously sold its second voucher to Bristol Myers Squibb for $95m

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FDA approves Santhera’s Duchenne muscular dystrophy drug Agamree

The rare muscle-wasting disorder is estimated to affect one in 3,500 male births worldwide

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Eli Lilly’s Omvoh granted FDA approval for ulcerative colitis

Inflammatory bowel disease is estimated to affect nearly one in every 100 people in the US

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FDA approves Servier’s Tibsovo as first targeted therapy for rare blood cancer

Approximately 16,000 people in the US are diagnosed with myelodysplastic syndromes every year

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Pfizer’s pentavalent meningococcal vaccine granted FDA approval

Penbraya helps protect against the five most common meningococcal serogroups

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FDA approves UCB’s inflammatory disease drug Bimzelx for plaque psoriasis

More than 7.5 million adults in the US are affected by some form of the chronic inflammatory condition

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Merck’s Keytruda granted FDA approval for expanded use in lung cancer

The approval marks the sixth non-small cell lung cancer indication for the anti-PD-1 therapy

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Bristol Myers Squibb’s Opdivo approved by FDA for expanded melanoma use

More than 97,000 cases of melanoma are expected to be diagnosed in the US in 2023

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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

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