Yahoo Finance11d
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 ... is currently approved in the United States for patients with advanced ...
Hosted on MSN17d
Scilex FDA submission for ELYXYB acute pain treatment acknowledged
The acknowledgment of the SNDA by the FDA is a procedural ... received and will undergo a review process. However, it does not imply any form of approval or assessment of the drug's efficacy ...
Cure Today10d
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 pheochromocytoma and paraganglioma.
Business Insider18d
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 ... The approval is supported by ...
Yahoo Finance18d
SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
TITUSVILLE, N.J., Jan. 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA ...
Business Insider1mon
FDA To Decide On Agios' Request For Expanded Approval Of PYRUKYND In Thalassemia By September 7.
(RTTNews) - Agios Pharmaceuticals, Inc. (AGIO), on Wednesday, announced that its supplemental New Drug Application seeking approval for ... 2025. The sNDA submission is based on positive data ...