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digital therapeutics

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US FTC challenges more than 100 patents as ‘improperly listed’ with FDA

The agency has sent letters to ten companies including AbbVie, AstraZeneca and GSK

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FDA grants fast track designation to AviadoBio’s dementia gene therapy

The regulator has also given clearance for the candidate to be studied in frontotemporal dementia patients

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Merck’s Keytruda combination granted FDA approval for biliary tract cancer

Approximately 20,000 people are diagnosed with the disease each year in the US

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Amgen’s Wezlana receives FDA approval to treat multiple inflammatory diseases

Wezlana is approved as a biosimilar referencing Janssen Pharmaceuticals’ Stelara

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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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