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Ipsen's rare disease drug palovarotene knocked back in EU

Ipsen has suffered a setback in its marathon effort to bring palovarotene to market for ultra rare disease fibrodysplasia ossificans progressiva (FOP), after EU advisors recommended against

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J&J copay lawsuit against drug benefit firm gets green light

Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients o

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EU clears Enhertu for HER2-low breast cancer

The European Commission has approved Daiichi Sankyo and AstraZeneca's Enhertu as the first targeted therapy for HER2-low breast cancer, unlocking a large population of patients who could be

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FDA advisors back Cidara antifungal rezafungin

An FDA advisory committee has recommended approval of Cidara Therapeutics' once-weekly antifungal therapy rezafungin, setting it up to become the first new option for severe infections caus

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ALS drug tofersen will face FDA advisors, says Biogen

Biogen will have to make the case for its amyotrophic lateral sclerosis (ALS) therapy tofersen to an FDA advisory committee in March before it gets a decision on approval.

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FDA blocks early nod for Lilly's Alzheimer's drug donanemab

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer's disease therapy donanemab based on mid-stage clinical results, but says it remains on track

Ipsen's rare disease drug palovarotene knocked back in EU

J&J copay lawsuit against drug benefit firm gets green light

EU clears Enhertu for HER2-low breast cancer

FDA advisors back Cidara antifungal rezafungin

ALS drug tofersen will face FDA advisors, says Biogen

FDA blocks early nod for Lilly's Alzheimer's drug donanemab

FDA relents and will review Moderna's flu shot

How to meet your physicians where they are online

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