The European Commission has granted Orphan Designation for PBKR03, a treatment from Passage Bio to treat Krabbe disease. Krabbe disease is a rare lysosomal storage disorder that currently does not have any approved disease-modifying treatments. The approval comes...
The European Commission released a roadmap for its planned revision of pharmaceutical legislation for next year. With the adoption of the new strategy, which is “intended to make the European pharmaceutical system patient-centered, future-proof and...
The U.S. Food and Drug Administration (FDA) approved of two treatments to treat high blood pressure (pulmonary hypertension) and cancer (multiple myeloma). United Therapeutics won approval for Tyvaso (treprostinil) Inhalation Solution, its pulmonary hypertension...
The U.S. Food and Drug Administration (FDA) granted Premia Spine’s TOPS™ Spinal Arthroplasty System Breakthrough Device Designation to treat patients diagnosed with spinal stenosis and spondylolisthesis. The approval marks the first ever joint replacement system...
The U.S. Food and Drug Administration (FDA) has issued 22 new and 14 revised product-specific guidances (PSGs) for generic drug development. The guidances provide further clarity to the FDA’s expectations in regards to clinical studies demonstrating...
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