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 ...
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 ...
Scilex FDA submission for ELYXYB acute pain treatment acknowledged
PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug ...
Yahoo Finance4d
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 ...
Business Insider11d
JNJ's SNDA For Spravato Monotherapy Gets FDA Approval For Treatment-Resistant Depression
(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 ...
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 ...