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Mashup Score: 0Unlocking Treatment Possibilities in PBC - 12 hour(s) ago
For US Healthcare Professionals Rush University Medical Center Chicago, IL Liver Institute Northwest Seattle, WA Weill Cornell Medical College New York, NY Rush University Medical Center Chicago, IL Liver Institute Northwest Seattle, WA Weill Cornell Medical College New York, NY Myalgia, Myopathy, and Rhabdomyolysis: Rhabdomyolysis resulting in acute kidney injury occurred in one IQIRVO-treated patient who had cirrhosis at baseline and was also taking a stable dose of an HMG-CoA reductase inhibitor
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet
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Mashup Score: 1
The CRL is consistent with the outcome of a September Gastrointestinal Drugs Advisory Committee meeting.
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
BREAKING: The US Food and Drug Administration has issued a Complete Response Letter to Intercept Pharmaceuticals’ obeticholic acid (Ocaliva) for the treatment of #PBC, denying to approve the supplemental New Drug Application in its current form. https://t.co/v9qGPLa4cV https://t.co/Nf39O08r7h
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Mashup Score: 1
The CRL is consistent with the outcome of a September Gastrointestinal Drugs Advisory Committee meeting.
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
BREAKING: The US Food and Drug Administration has issued a Complete Response Letter to Intercept Pharmaceuticals’ obeticholic acid (Ocaliva) for the treatment of #PBC, denying to approve the supplemental New Drug Application in its current form. https://t.co/v9qGPLa4cV https://t.co/Nf39O08r7h
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Mashup Score: 1FDA Extends Review of Obeticholic Acid (Ocaliva) sNDA for Primary Biliary Cholangitis - 2 month(s) ago
The FDA has extended its review of the sNDA, delaying the previous October 15, 2024, PDUFA date, without providing a new anticipated action date.
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
BREAKING: The FDA has extended its review of Intercept Pharmaceuticals’ sNDA for obeticholic acid (Ocaliva) for the treatment of #PBC. The FDA has not provided a new anticipated action date. Learn more: https://t.co/biDqOlorn3 https://t.co/91Way9Z9Ho
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Mashup Score: 1FDA Extends Review of Obeticholic Acid (Ocaliva) sNDA for Primary Biliary Cholangitis - 2 month(s) ago
The FDA has extended its review of the sNDA, delaying the previous October 15, 2024, PDUFA date, without providing a new anticipated action date.
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
BREAKING: The FDA has extended its review of Intercept Pharmaceuticals’ sNDA for obeticholic acid (Ocaliva) for the treatment of #PBC. The FDA has not provided a new anticipated action date. Learn more: https://t.co/biDqOlorn3 https://t.co/91Way9Z9Ho
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Mashup Score: 1FDA Extends Review of Obeticholic Acid (Ocaliva) sNDA for Primary Biliary Cholangitis - 2 month(s) ago
The FDA has extended its review of the sNDA, delaying the previous October 15, 2024, PDUFA date, without providing a new anticipated action date.
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
BREAKING: The FDA has extended its review of Intercept Pharmaceuticals’ sNDA for obeticholic acid (Ocaliva) for the treatment of #PBC. The FDA has not provided a new anticipated action date. Learn more: https://t.co/biDqOlorn3 https://t.co/91Way9Z9Ho
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Mashup Score: 0
Positive 120-day data from the phase 2a study of CNP-104 in PBC highlight its efficacy across multiple immunological and clinical measurements
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
Positive 120-day data from a phase 2a study of CNP-104 in #PBC highlight its potential efficacy across multiple immunological and clinical measurements, suggesting CNP-104 may be poised to become the first disease-modifying PBC treatment. Learn more: https://t.co/XxQxAku5lm
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Mashup Score: 0European Commission Revokes Obeticholic Acid (Ocaliva) CMA for Primary Biliary Cholangitis - 3 month(s) ago
The decision to revoke the conditional marketing authorization is based on a June 2024 CHMP recommendation from the EMA suggesting the benefits of Ocaliva do not outweigh its risks.
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
The European Commission revoked obeticholic acid (Ocaliva)’s CMA in Europe for the second-line treatment of #PBC. The FDA will hold an advisory committee meeting on September 13, 2024, to discuss accelerated approval postmarketing requirements in the US. https://t.co/aeDblubT5F https://t.co/XDlEbTseVC
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Mashup Score: 0European Commission Revokes Obeticholic Acid (Ocaliva) CMA for Primary Biliary Cholangitis - 3 month(s) ago
The decision to revoke the conditional marketing authorization is based on a June 2024 CHMP recommendation from the EMA suggesting the benefits of Ocaliva do not outweigh its risks.
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
The European Commission revoked obeticholic acid (Ocaliva)’s CMA in Europe for the second-line treatment of #PBC. The FDA will hold an advisory committee meeting on September 13, 2024, to discuss accelerated approval postmarketing requirements in the US. https://t.co/aeDblubT5F https://t.co/XDlEbTseVC
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Mashup Score: 0FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis - 4 month(s) ago
The accelerated approval is based on phase 3 data demonstrating seladelpar’s impact on ALP reduction and is contingent upon verification and description of clinical benefit in confirmatory trial(s).
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
The FDA has granted accelerated approval to @GileadSciences seladelpar (Livdelzi) for the treatment of #PBC in combination with UDCA in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Learn more: https://t.co/U2l7f1HrnF https://t.co/yQG52DDLeB
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Learn key aspects of #PBC relevant to patient management and historical treatment approaches. Watch the On-Demand Broadcast to hear experts discuss the phase 3 clinical trial and evaluate the safety and efficacy results. https://t.co/089ItaxcQk https://t.co/AduQmIbUiO