regulatory approval

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UCB bags FDA okay for first drug to treat rare disease TK2d

People living with thymidine kinase 2 deficiency (TK2d), a vanishingly rare and often fatal genetic disorder, finally have an approved therapy.

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GSK's Blenrep's back in US, but with a narrower label

Against the odds, GSK has secured FDA approval for its multiple myeloma therapy Blenrep, three years after it was removed from sale.

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Amgen, AZ's Tezspire challenges Dupixent in nasal polyps

Amgen and AstraZeneca's fast-growing asthma drug Tezspire is now poised to take on rival Dupixent in chronic rhinosinusitis with nasal polyps.

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FDA clears Roche, Lilly Alzheimer's blood test

A blood test developed by Roche and Eli Lilly that could help diagnose patients with Alzheimer's more quickly has been approved by the FDA.

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Kelun gets world-first approval for TROP2 ADC

Kelun-Biotech has picked up another world-first approval for its TROP2-targeting ADC sac-TMT in non-small cell lung cancer.

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Regeneron's Libtayo stakes out new territory in skin cancer

Regeneron's Libtayo has become the first checkpoint inhibitor to be cleared by the FDA as an adjuvant treatment for cutaneous squamous cell carcinoma.

UCB bags FDA okay for first drug to treat rare disease TK2d

GSK's Blenrep's back in US, but with a narrower label

Amgen, AZ's Tezspire challenges Dupixent in nasal polyps

FDA clears Roche, Lilly Alzheimer's blood test

Kelun gets world-first approval for TROP2 ADC

Regeneron's Libtayo stakes out new territory in skin cancer

Are Makary's priority review vouchers about to be canned?

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regulatory approval

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