Gilead Sciences, Inc. today announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis (PBC) in ...

(GILD) announced that the European Commission has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis in combination with ursodeoxycholic ...

Participants in the RESPONSE trial received a daily oral dose of 10 mg of seladelpar ... in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA ...

(Ursodiol [Urso] is a prescription medication ... The recommended starting dosage of Ocaliva is 5 mg once daily. After 3 months, your doctor may increase your dosage to 10 mg once daily.

Participants in the RESPONSE trial received a daily oral dose of 10 mg of seladelpar or placebo for 12 months ... U.S. Indication for Livdelzi Livdelzi is indicated for the treatment of primary ...

Iqirvo (elafibranor) is also the first new therapy for PBC in more than a decade, getting a green light as a second-line therapy in combination with ursodeoxycholic ... an 80 mg dose of ...

Regulatory News: Sensorion (FR0012596468 ? ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss ...

The approval covers seladelpar's use in combination with ursodeoxycholic acid (UDCA ... plus a fourth dose 30 days after the third. The drug is currently approved in 12 mg doses.

Relapse is common, and long-term low-dose prednisone or azathioprine therapy is preferred after multiple relapses. Sustained remission is achievable, even after relapse, in 47% within 10 years ...

That leap forward came at a sky-high price: more than $2 million per dose, making Zolgensma then the costliest one-time treatment ever. How did a drug rooted, like many, in seed money from the U.S ...