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 ...
FiercePharma3d
EMA backs Merck's Welireg, Bayer's ATTR med and Gilead's liver drug from $4.3B deal
Merck & Co.’s kidney cancer drug Welireg, Bayer and BridgeBio’s transthyretin amyloid cardiomyopathy (ATTR-CM) therapy, and ...
Business Insider3d
Gilead Sciences Says Seladelpar Gets Positive CHMP Opinion For Primary Biliary Cholangitis
(RTTNews) - Gilead Sciences, Inc. (GILD) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending ...
PharmTech3h
Several Orphan Drugs Among Medicines Recommended for Approval by EMA in December
EMA recommended 17 drugs for marketing authorization in December, including treatments for rare heart conditions, anemia, and liver disease.
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 ...
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 ...
Morningstar1mon
Gilead’s Livdelzi (Seladelpar) Demonstrated a Sustained Efficacy and Long-Term Safety Profile in Management of Primary Biliary Cholangitis
“These data support what we’ve already observed with seladelpar. The long-term data from the ASSURE study reinforce that seladelpar consistently lowers ALP, offering a promising and much ...
MarketWatch3d
Gilead Gets Key European Backing for Liver-Disease Treatment
Gilead Sciences said a key European regulatory committee recommended expanded approval of its seladelpar treatment for patients with primary biliary cholangitis, a chronic and progressive liver ...
Benzinga.com1mon
Gilead Unveils Long-Term Data From Seladelpar In Patients With Rare Liver Disease
The study showed that 81% (30 out of 37) of participants with primary biliary cholangitis (PBC) treated with Livdelzi (seladelpar) achieved a composite biochemical response (CBR), demonstrating ...
Yahoo Finance1mon
Gilead’s Livdelzi (Seladelpar) Demonstrated a Sustained Efficacy and Long-Term Safety Profile in Management of Primary Biliary Cholangitis
– Livdelzi Reduced Pruritus Severity in PBC Participants and Led to Near Resolution of Itch in 27% of Participants with Moderate to Severe Itch – FOSTER CITY, Calif., November 15, 2024 ...