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Displaying Results 101-105 of 105 "'SNDA'"

Jun 17, 2025, 17:31 ET Chronic Hepatitis B Market--The US to Have the Lion's Share Among the 7MM, Predicts DelveInsight

formulated as an oral tablet. In March 2024, Gilead announced that the FDA had approved a supplemental New Drug Application (sNDA) for VEMLIDY 25 mg, allowing its once-daily use in pediatric patients aged 6 years and older and weighing at least 25 kg who have chronic hepatitis

More news about: DelveInsight Business Research, LLP


Jun 12, 2025, 09:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX

("FDA") "has indicated that it is currently planning to hold an advisory committee meeting to discuss" the Company's "supplemental New Drug Application (sNDA) for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS)."  On this news, Travere's

More news about: Pomerantz LLP


Jun 10, 2025, 07:05 ET Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage Small Cell Lung Cancer

Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first-line maintenance treatment for people

More news about: Jazz Pharmaceuticals plc


Jun 07, 2025, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX

("FDA") "has indicated that it is currently planning to hold an advisory committee meeting to discuss" the Company's "supplemental New Drug Application (sNDA) for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS)."  On this news, Travere's

More news about: Pomerantz LLP


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