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Roche gets EU nod for kidney disease algorithm

Roche and Klinrisk have picked up a CE-mark for an AI tool that can be used to predict renal function decline in patients with chronic kidney disease.

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Jazz, Roche combo cleared by FDA for lung cancer

Can FDA approval of Jazz Pharma's Zepzelca in a combination regimen for extensive-stage small cell lung cancer return sales of the drug to growth?

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FDA angers anti-abortion lobby with generic abortion pill OK

The FDA has cleared another generic of the abortion pill mifepristone, as it carries out a review of the drug that has been criticised as spurious.

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FDA clears Novartis' oral drug for chronic hives

Novartis has claimed a first-in-class approval in the US for its oral BTK inhibitor remibrutinib as a treatment for chronic spontaneous urticaria.

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Lilly brings second oral SERD to market for breast cancer

Lilly's Inluriyo is the second oral SERD to reach the US market for ESR1-mutated breast cancer, setting up a market tussle with Menarini's Orserdu.

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The Biolinq continuous glucose monitor in a person's arm

Biolinq bags FDA okay for autonomous glucose sensor

Biolinq gets an FDA green light for its autonomous, needle-free continuous glucose monitor, plus a roundup of other medtech developments.

Roche gets EU nod for kidney disease algorithm

Jazz, Roche combo cleared by FDA for lung cancer

FDA angers anti-abortion lobby with generic abortion pill OK

FDA clears Novartis' oral drug for chronic hives

Lilly brings second oral SERD to market for breast cancer

Biolinq bags FDA okay for autonomous glucose sensor

Repligen builds in cell therapy with $1.5bn BioLife takeover

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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