FDA Gives PulmoSIM’s PT001 Orphan Drug Designation for PAH

FDA Gives PulmoSIM’s PT001 Orphan Drug Designation for PAH

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FDA Gives PulmoSIM’s PT001 Orphan Drug Designation for PAH

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT001, an investigational treatment for pulmonary arterial hypertension (PAH). The FDA gives this designation to therapies with the potential to treat rare disorders, defined as those that affect fewer than 200,000 people in the U.S. The designation gives PT001’s developer, PulmoSIM Therapeutics, access to certain waived fees, tax credits in clinical research expenses, regulatory assistance, as well as the potential for seven years…

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