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NEW YORK - OS Therapies Inc. (NYSE-A: OSTX), a biotechnology firm specializing in cancer immunotherapies with a current market capitalization of $45.8 million, has requested the U.S. Food and Drug ...
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Ionis Pharmaceuticals IONS announced that the FDA has granted the Breakthrough Therapy designation to its pipeline candidate, ION582, for the treatment of Angelman syndrome (AS), a rare neurological ...
A monthly antibody drug to treat sickle cell disease, developed by Novartis, has won a coveted breakthrough designation from the FDA as it heads towards its first regulatory filings. The US regulator ...
ZUG, Switzerland and BOSTON - CRISPR Therapeutics (NASDAQ:CRSP), a leader in gene-based medicine with a market capitalization of $4.3 billion, reported significant advancements in their ongoing Phase ...
The FDA authorization process can be an unwieldy one, but it’s necessary to ensure that all medical products on the market are safe, effective and consistent in quality. The target of that Jan. 28 ...
Biogen's Salanersen secures FDA Breakthrough Therapy designation for SMA after phase Ib data showed motor gains and supports once-yearly dosing.