The sNDA has been accepted for review under the FDA’s Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the ...

Hosted annually in February by the school’s national award-winning Student National Dental Association (SNDA) chapter. The program exposes pre-dental college students to a career in dentistry through ...

The FDA has assigned the Priority Review status to the company’s sNDA for the combination therapy ... under the FDA’s accelerated approval pathway. Continued approval for this indication ...

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 ...

(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 ...

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration accepted the revised supplemental New Drug Application or sNDA for IZERVAY (avacincaptad pegol ...