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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 ...
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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.
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 ...
Johnson & Johnson announces FDA approves sNDA for Spravato
Johnson & Johnson announced the U.S. FDA approval of a supplemental New Drug Application for Spravato CIII nasal spray, making this ...
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MannKind Corporation to Discuss Afrezza Diabetes Study Results and Upcoming FDA Meeting Plans
MannKind Corporation plans to meet with the FDA regarding a potential supplemental new drug application (sNDA) submission, which could accelerate the approval process for Afrezza in children and ...