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Mashup Score: 1FDA Extends Review of Obeticholic Acid (Ocaliva) sNDA for Primary Biliary Cholangitis - 9 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
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Mashup Score: 1FDA Extends Review of Obeticholic Acid (Ocaliva) sNDA for Primary Biliary Cholangitis - 9 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 - 9 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 - 10 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 - 10 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 - 11 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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Mashup Score: 5Shifting Treatment Goals, Timelines in Primary Biliary Cholangitis - 11 month(s) ago
In this video segment, Reau, Trivedi, and Hirschfield discuss recent shifts in treatment goals for patients with PBC and a new focus on timely intervention with second-line options.
Source: www.hcplive.comCategories: General Medicine News, General HCPsTweet-
Following the FDA accelerated approval of seladelpar (Livdelzi) for the treatment of #PBC, @CholestasisDoc @NancyReau and Gideon Hirschfield, PhD, MB BChir discussed the evolving landscape of PBC management in this 6-part HCPLive Special Report: https://t.co/5eRNdaLRoo https://t.co/zbAkTcbuhE
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Mashup Score: 0FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis - 11 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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Mashup Score: 0FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis - 11 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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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