Category: North America

April 20, 2022 Off

GSK’s Daprodustat Receives FDA Filing Acceptance

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The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for GlaxoSmithKline’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD).

April 15, 2022 Off

Nektar and BMS End Clinical Development of Bempegaldesleukin in Combination with Opdivo

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Nektar Therapeutics (NASDAQ: NKTR) and Bristol Myers Squibb (NYSE: BMY) have announced that based on results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer, the companies have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo.

April 13, 2022 Off

FDA Doesn’t Give Myovant Sciences-Pfizer’s Pain Killer sNDA

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Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) have announced an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.