Biologically Active Substance
Compounders Sue FDA Over Removal of Semaglutide from Drug Shortage List
Semaglutide, FDA, drug shortage, compounders, lawsuit, Ozempic, Wegovy, Outsourcing Facilities Association
Hims eyes growth in its weight loss business, despite end of semaglutide shortage
semaglutide, weight loss business, United States Food and Drug Administration, Growth, Hims
Entrada given go-ahead to test DMD therapy after two-year hold
Entrada, Muscular Dystrophy, Duchenne, DMD, United States Food and Drug Administration, Adult, Exons
FDA Approves Mirum’s Ctexli as First Treatment for Rare Lipid Disorder CTX
Ctexli, chenodiol, cerebrotendinous xanthomatosis (CTX), FDA approval, Mirum Pharmaceuticals, rare metabolic disorder, lipid storage disease, bile acid therapy
Gilead’s Seladelpar Receives Conditional EU Approval for Primary Biliary Cholangitis Treatment
Seladelpar, Gilead Sciences, primary biliary cholangitis, PBC, European Commission, conditional marketing authorization, RESPONSE trial, ursodeoxycholic acid (UDCA)
BridgeBio’s Attruby Gains FDA Approval, Challenging Pfizer’s Tafamidis in ATTR-CM Treatment
Attruby, acoramidis, BridgeBio, ATTR-CM, tafamidis, Pfizer, FDA approval, transthyretin stabilizer, cardiomyopathy
Merck & Co. Partners with Epitopea to Explore ‘Junk DNA’ for Novel Cancer Antigens
Merck & Co., Epitopea, cancer immunotherapy, Cryptigen tumor-specific antigens, CryptoMap platform, junk DNA, off-the-shelf immunotherapies
FDA Approves Ono’s Romvimza for Rare Joint Tumor, Challenging Daiichi Sankyo’s Turalio
Romvimza, vimseltinib, tenosynovial giant cell tumor (TGCT), Ono Pharmaceutical, FDA approval, Daiichi Sankyo, Turalio, CSF1 inhibitor, rare joint tumor
Arcus Biosciences Advances Promising Kidney Cancer Drug Casdatifan After Gilead Opts Out
Arcus Biosciences, casdatifan, HIF-2a inhibitor, kidney cancer, clear cell renal cell carcinoma (ccRCC), Gilead Sciences, clinical trial data, $150 million stock offering