regulatory approval

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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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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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FDA clears first anaphylaxis nasal spray at second attempt

ARS Pharma has claimed FDA approval for its epinephrine nasal spray neffy, becoming the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.

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Second time lucky at FDA for Citius' lymphoma drug

At the second attempt, the FDA has approved Citius Pharmaceuticals' marketing application for Lymphir, a new version of a lymphoma therapy withdrawn from sale several years ago.

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Novartis gets FDA OK for first in its trio of IgAN therapies

Novartis has claimed accelerated approval from the FDA for a second indication for Fabhalta – IgA nephropathy (IgAN) – as it charts a course to blockbuster sales for the drug.

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Servier bags FDA okay for glioma drug from $2bn Agios buy

The FDA has approved Servier's vorasidenib for two forms of glioma, becoming the first targeted therapy for this aggressive and incurable form of brain cancer.

Galderma gets FDA nod for prurigo nodularis therapy

FDA okays Ascendis hypoparathyroidism drug at second attempt

FDA clears first anaphylaxis nasal spray at second attempt

Second time lucky at FDA for Citius' lymphoma drug

Novartis gets FDA OK for first in its trio of IgAN therapies

Servier bags FDA okay for glioma drug from $2bn Agios buy

Neurogene drops high-dose arm in Rett study after death

Coming soon: The Life Sciences Industry Report 2025 – insigh...

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