Serodus announces orphan drug designation for its leading product, SER100 by US Food and Drug Administration (FDA) for the treatment of Pulmonary Arterial Hypertension (PAH). The company is planning for first clinical study in phase IIa or combined phase IIa/III study in patients with PAH.
The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.
For Orphan Drug Clinical Insight Reports Contact: firstname.lastname@example.org
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