Af­ter two CRLs, FDA ap­proves scPhar­ma­ceu­ti­cal­s' drug-de­vice as biotech nabs $100M to fund launch

FDA has fi­nal­ly ac­cept­ed scPhar­ma­ceu­ti­cals’ prod­uct for ap­proval — and the com­pa­ny is now hunt­ing the mon­ey to push it to mar­ket.

scPhar­ma­ceu­ti­cals made a dual an­nounce­ment Mon­day morn­ing: one, that its sub­cu­ta­neous for­mu­la­tion of furosemide, called Furoscix and de­liv­ered by a wear­able de­vice, has been ap­proved by the FDA to treat flu­id over­load in pa­tients with spe­cif­ic types of heart fail­ure; and two, that the biotech is fi­nal­iz­ing a $100 mil­lion raise to push the drug to mar­ket. The price has not yet been dis­closed.

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