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Bayer expands indications for Nubeqa with new drug application
TheUS Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for its oral androgen receptor inhibitor (ARi), for the treatment of patients with ...
Nasdaq1mon
FDA APPROVES ACETADOTE® sNDA
By streamlining the administration process, we aim to enhance patient outcomes and reduce the burden on health care providers." FDA-approved sNDA adds a simplified, IV NAC dosing regimen to the ...
Nasdaq4d
MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority Tag
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 ...
Cure Today3d
FDA Accepts sNDA for Welireg in Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
Business Insider10d
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, and the European Medicines Agency, EMA, has validated ...
Business Insider24d
FDA Accepts Astellas Pharma's Revised SNDA For IZERVAY In Geographic Atrophy Treatment
(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 ...