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 ...
Nasdaq4d
MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority Tag
Currently, there are no approved therapies for treating these rare adrenal tumors. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on May 26 ...
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 ...
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 ...
Morningstar11d
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) ...
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the ...