regulatory approval

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PBC drug choices rise in US with OK for Gilead's seladelpar

At the start of the year, there had been no new therapies for rare cholestatic liver disease primary biliary cholangitis (PBC) in the US for almost a decade.

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Incyte builds GvHD presence with Niktimvo approval

The FDA has approved Incyte's axatilimab as a treatment for chronic graft-versus-host disease (GvHD), making it a companion to the company's Jakafi for the disorder.

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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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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.

PBC drug choices rise in US with OK for Gilead's seladelpar

Incyte builds GvHD presence with Niktimvo approval

AZ gets landmark approval for Imfinzi/Lynparza combo

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

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

regulatory approval

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