The disease gradually takes away the skills children have learned—leading to seizures, movement difficulties and profound ...
Der "Breakthrough Therapy"-Status ermöglicht Spruce Biosciences eine intensivere Betreuung durch die FDA, eine fachübergreifende Zusammenarbeit sowie die Möglichkeit einer schrittweisen Einreichung ...
Denali Therapeutics faces an FDA review delay for its Hunter syndrome drug, pushing potential approval of tividenofusp alfa to April 2026.
Breakthrough Therapy Designation Supported by Integrated Long-Term Clinical Data Demonstrating Normalization in Cerebral Spinal Fluid Heparan Sulfate Non-Reducing End (CSF HS-NRE) U.S. FDA Confirmed ...
President Donald Trump’s first term championed a vision of American healthcare rooted in innovation, patient choice, and ...
Investing.com -- Spruce Biosciences (NASDAQ:SPRB) stock surged 60% after the company announced it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its ...
Shares of Spruce Biosciences were lower after the company said it had agreed to sell shares in a private placement expected to raise $50 million in gross proceeds. The stock fell 23% to $140 in ...
Ultragenyx (RARE) stock is down 40% since March 2024 amid ongoing financial struggles. See more insights on its growth ...
Denalis aussichtsreichste Kandidaten durchlaufen derzeit entscheidende regulatorische Phasen. Der größte Hoffnungsträger ist tividenofusp alfa für die seltene Hunter-Syndrom-Erkrankung. Die ...
The microcap biotech stock had its best day ever after the FDA granted its rare-disease drug a breakthrough designation.
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