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GILD Obtains Positive CHMP Opinion for Liver Disease Drug
Gilead Sciences, Inc. GILD announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European ...
MedPage Today on MSN4d
FDA Issues Safety Alert on Liver Disease Drug
Postmarketing data on obeticholic acid (Ocaliva) identified a risk for serious liver injury in primary biliary cholangitis ...
Gilead gets positive EU regulatory opinion for seladelpar
Gilead Sciences (NASDAQ:GILD) has received a positive recommendation for approval from European regulators for its drug ...
Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the ...
MarketWatch3d
Gilead Gets Key European Backing for Liver-Disease Treatment
The biopharmaceutical company Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers seladelpar in combination with ursodeoxycholic ...
Business Insider3d
Gilead Sciences Says Seladelpar Gets Positive CHMP Opinion For Primary Biliary Cholangitis
RESPONSE is a Phase 3, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of seladelpar in adults with PBC who have shown inadequate response or intolerance ...
Benzinga.com1mon
Gilead Unveils Long-Term Data From Seladelpar In Patients With Rare Liver Disease
In August, the FDA granted accelerated approval for Gilead’s Livdelzi for primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate ...
Business Wire1mon
Gilead’s Livdelzi (Seladelpar) Demonstrated a Sustained Efficacy and Long-Term Safety Profile in Management of Primary Biliary Cholangitis
U.S. Indication for Livdelzi Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate ...
Medscape3d
EMA Recommends Seladelpar for Primary Biliary Cholangitis
The EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that expected clinical benefits of seladelpar include delayed development of liver fibrosis and cirrhosis, potentially ...
Gilead announces positive CHMP opinion for seladelpar
Sciences announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive ...
Medscape11y
The Role of Ursodeoxycholic Acid in Non-alcoholic Steatohepatitis
Effective therapy for NASH is still lacking. In this study, we investigated the effects of Ursodeoxycholic acid (UDCA) in the treatment of NASH. Methods: Western and Chinese databases were ...