The start of the review sets up an FDA decision by 1 February next year and – if positive – could give GSK first-to-market advantage in the HIF-PHI class after two competing agents were turned ...

The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for ... Earlier this month, the FDA said it wanted to see another clinical trial of roxadustat before it ...

Despite finally winning a hard-fought FDA approval for its chronic kidney disease (CKD) anemia drug Vafseo last year, Akebia ...

The FDA has now notified the company that its sNDA ... zanzalintinib with Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan) in a phase I/II study and two ...

which is also a HIF-2a inhibitor. Welireg won its second FDA approval in relapsed or refractory renal cell carcinoma in December after being initially approved to treat the rare disease von Hippel ...

3. FDA approves Ono's rare tumor drug from $2.4B Deciphera buyout Ono Pharmaceutical’s Deciphera Pharmaceuticals has won FDA approval for Romvimza as a competitor to Daiichi Sankyo’s Turalio ...