May 17, 2023 10:56 AM EDT

Priority review for Takeda’s ultra-rare blood clot ERT; FDA to give another look at Ardelyx’s CKD drug

Kyle LaHucik

Senior Reporter

Max Gelman

Senior Editor

The FDA will review Takeda’s enzyme replacement therapy for an ultra-rare blood clotting disorder and decide whether to approve it within six months, the Japanese …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER

Priority review for Takeda’s ultra-rare blood clot ERT; FDA to give another look at Ardelyx’s CKD drug

Kyle LaHucik

Senior Reporter

Max Gelman

Senior Editor

Sign up to read this article for free.

Among pharma CEOs, the IRA now and the IRA later get very different reactions

Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year

Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another

Andrew Left, short seller who campaigned against Valeant, is accused of fraud by SEC

European drug regulator rejects Alzheimer's drug Leqembi, citing safety concerns

Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?

Pri­or­i­ty re­view for Take­da’s ul­tra-rare blood clot ERT; FDA to give an­oth­er look at Arde­lyx’s CKD drug

Senior Reporter

Senior Editor

Sign up to read this article for free.

Priority review for Takeda’s ultra-rare blood clot ERT; FDA to give another look at Ardelyx’s CKD drug