regulatory approval

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At second ask, FDA clears AZ’s Ultomiris for NMOSD

AstraZeneca’s Ultomiris has been approved by the FDA to treat rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD), six months after an earlier applicati

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FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

Italfarmaco’s oral HDAC inhibitor givinostat has been approved in the US as a treatment for Duchenne muscular dystrophy (DMD), becoming the first non-steroidal option for

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Idorsia first-in-class hypertension drug gets FDA okay

Idorsia Pharmaceuticals has claimed FDA approval for aprocitentan as a treatment for resistant hypertension, becoming the first drug in the endothelin receptor antagonist

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Iclusig gets FDA nod as frontline therapy for rare leukaemia

Takeda’s Iclusig has become the first targeted therapy approved by the FDA for use alongside chemotherapy as a first-line therapy for a rare form of acute lymphoblastic le

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Orchard's gene therapy for MLD finally gets US approval

The FDA has cleared its first gene therapy for kids with metachromatic leukodystrophy (MLD), a rare genetic disorder of the brain and nervous centre.

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Madrigal Pharma is first over the MASH finish line

Madrigal Pharma has become the first drugmaker to claim FDA approval for a drug to treat metabolic dysfunction-associated steatohepatitis (MASH), an elusive target that ha

At second ask, FDA clears AZ’s Ultomiris for NMOSD

FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

Idorsia first-in-class hypertension drug gets FDA okay

Iclusig gets FDA nod as frontline therapy for rare leukaemia

Orchard's gene therapy for MLD finally gets US approval

Madrigal Pharma is first over the MASH finish line

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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