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AZ gets landmark approval for Imfinzi/Lynparza combo

AstraZeneca has become the first company to get approval for the combination of an immunotherapy with a PARP inhibitor for treating endometrial cancer.

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prescription digital therapeutic on a smartphone

Otsuka, Click's depression DTx launches in the US

An FDA-approved digital therapeutic (DTx) that can be used to help people living with major depressive disorder (MDD) has been launched in the US and is available in mobile app stores.

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Galderma's chief executive Flemming Ørnskov

Galderma gets FDA nod for prurigo nodularis therapy

Dermatology specialist Galderma has FDA approval for prurigo nodularis treatment Nemluvio, one of two new drugs that it thinks will deliver blockbuster sales.

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Judge rebuffs Novartis bid to block generic Entresto

A judge in the US has denied an attempt by Novartis to stop MSN Pharmaceuticals from launching a generic version of heart failure blockbuster Entresto.

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FDA okays Ascendis hypoparathyroidism drug at second attempt

After turning it down a year ago, the FDA has cleared once-daily injectable Yorvipath for hypoparathyroidism from Ascendis Pharma.

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Article retractions muddy MDMA waters after FDA denial

The journal Psychopharmacology has retracted three articles about MDMA-assisted psychotherapy, shortly after the FDA rejected approval of Lykos Therapeutics' therapy for post-traumatic stre

AZ gets landmark approval for Imfinzi/Lynparza combo

Otsuka, Click's depression DTx launches in the US

Galderma gets FDA nod for prurigo nodularis therapy

Judge rebuffs Novartis bid to block generic Entresto

FDA okays Ascendis hypoparathyroidism drug at second attempt

Article retractions muddy MDMA waters after FDA denial

Biotech is back, with Craig Ackerman

Using AI-driven synthetic personas to take your insights fur...

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