Marthe Fourcade

2 months ago | bloomberg.com | Marthe Fourcade

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2 months ago | news.bloomberglaw.com | Marthe Fourcade

Indivior Plc said US regulators delayed a decision on label changes intended to boost its lead product, another blow to the struggling UK maker of opioid addiction medicines. The Food and Drug Administration, which had scheduled a decision by Feb. 7 under a priority review, informed the company about the delay on Tuesday, Indivior said in a statement.

Jun 10, 2024 | bnnbloomberg.ca | Marthe Fourcade

(Bloomberg) -- Ipsen SA and partner Genfit SA won US regulators’ clearance for the first new treatment option in eight years for patients with a rare liver disease. The US Food and Drug Administration approved the medicine, elafibranor, for adults with primary biliary cholangitis, an autoimmune disease in which the bile ducts become inflamed and slowly destroyed. The drug will be called Iqirvo, Ipsen said in a statement Monday.

Jun 10, 2024 | bloomberg.com | Marthe Fourcade

Ipsen SA and partner Genfit SA won US regulators’ clearance for the first new treatment option in eight years for patients with a rare liver disease. The US Food and Drug Administration approved the medicine, elafibranor, for adults with primary biliary cholangitis, an autoimmune disease in which the bile ducts become inflamed and slowly destroyed. The drug will be called Iqirvo, Ipsen said in a statement Monday.

May 27, 2024 | bnnbloomberg.ca | Marthe Fourcade

(Bloomberg) -- AstraZeneca Plc and partner Daiichi Sankyo Co.’s experimental drug Dato-DXd helped extend the lives of some lung cancer patients in a late-stage study. The drug already showed it could stave off cancer’s worsening last year. Now, researchers have looked at the data to determine whether it actually helped prolong patients’ lives — a key gauge called overall survival.