Welireg's sNDA for advanced PPGL treatment is under FDA priority review, potentially becoming the first U.S. therapy for this condition. The LITESPARK-015 trial supports the sNDA with ORR and DOR data ...

Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is ...

Scilex (SCLX) announced that it will be filing today of a Supplemental New Drug Application, SNDA, with the FDA for ELYXYB in acute pain indication. “We are well positioned to broaden the ELYXYB ...

Johnson & Johnson announced the U.S. FDA approval of a supplemental New Drug Application for Spravato CIII nasal spray, making this innovative treatment the first and only monotherapy for adults ...

(RTTNews) - Johnson & Johnson (JNJ), Tuesday announced that the U.S. Food and Drug Administration has approved supplemental New Drug Application or sNDA for Spravato, a monotherapy for adults with ...

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