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FDA to Review Novel Regimen for Treating Metastatic Pancreatic Ductal Adenocarcinoma

The FDA has accepted the sNDA for irinotecan liposome (Onivyde) plus 5-FU/leucovorin and oxaliplatin for metastatic pancreatic ductal adenocarcinoma.

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Ipsen Itching Drug Scratches Off a Second FDA Approval in Rare Liver Indication

Ipsen drug Bylvay is now FDA approved for treating pruritus, or severe itching, which is a complication of the rare liver disease Alagille syndrome. The oral drug was previously approved for treating pruritus in another rare inherited liver disease called PFIC.

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Ipsen s Bylvay approved by FDA for severe itching due to Alagille syndrome

Ipsen s Bylvay approved by FDA for severe itching due to Alagille syndrome
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Ipsen Pharma: Ipsen announces U S FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma

Supplemental New Drug Application (sNDA) submission based on the NAPOLI 3 Phase III trial1Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with few

France generalUnited kingdomUnited statesSan franciscoT ai peiElizabeth kalinaIpsen euronextHoward mayerGlobal head of franchise communicationsCommunications patient advocacyDrug administrationHead of researchSupplemental new drug applicationExecutive vice presidentPrescription drug user fee actIpsen fast track

Ipsen announces U S FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma

Supplemental New Drug Application submission based on the NAPOLI 3 Phase III trial1Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with few. | June 14, 2023

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