HealthQuill Duchenne muscular dystrophy
The Food and Drug Administration has come out with new product-specific guidances for developing generic drugs and generating evidence to support abbreviated new drug application approvals.
Drugs Health Pharma

FDA draws up new product guidance for developing generic drugs

HQ Team May 21, 2025: The Food and Drug Administration has come out with new product-specific guidances for developing generic drugs and generating.

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Italfarmaco SpA., a privately held Italian pharmaceutical and chemical company, received a recommendation for the conditional marketing in the European Union of an oral drug for Duchenne muscular dystrophy in patients six years or older, who can walk.
Drugs Medical Pharma

Italfarmaco gets conditional marketing nod in EU for DMD drug

HQ Team April 27, 2025: Italfarmaco SpA., a privately held Italian pharmaceutical and chemical company, received a recommendation for the conditional marketing in.

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Pfizer’s investigations on gene therapy for patients with Duchenne muscular dystrophy failed to meet its primary goals, according to a company statement.
Drugs Health Pharma

Pfizer’s Duchenne muscular dystrophy trial fails to meet primary goal

Pfizer’s investigations on gene therapy for patients with Duchenne muscular dystrophy failed to meet its primary goals, according to a company statement.

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Drugs Medical Pharma

FDA approves Santhera’s Agamree for Duchenne muscular dystrophy

HQ team October 31, 2023: The US Food and Drug Administration (FDA) has given the green light to Santhera Pharmaceuticals’ drug, Agamree (vamorolone),.

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