Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

RTTNews | 621 dias atrás
Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

(RTTNews) - Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is currently approved for use in 35 countries.

Based on standard NDA resubmission review timelines, a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date is expected in 30 days. Akebia expects the FDA to set a PDUFA date of six months from the date of submission.

For More Such Health News, visit rttnews.com

Etiquetas: AKBA
read more
Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday that the company expects to resubmit its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis by the end of the third quarter of 2023.
RTTNews | 656 dias atrás
FTSE 100 Advances; Persimmon, Marks & Spencer Among Top Gainers

FTSE 100 Advances; Persimmon, Marks & Spencer Among Top Gainers

Despite data showing an increase in the nation's unemployment rate, U.K. stocks are up in positive territory a little past noon on Tuesday on selective buying amid some optimism over the ongoing U.S.-China trade talks in London.
RTTNews | 20 minutos atrás
CAC 40 Down Marginally In Cautious Trade

CAC 40 Down Marginally In Cautious Trade

French stocks are largely subdued on Tuesday as investors refrain from making significant moves while awaiting the outcome of the ongoing trade talks between U.S. and Chinese officials in London.
RTTNews | 1 h 5 min atrás
Sensex, Nifty End Choppy Session Narrowly Mixed

Sensex, Nifty End Choppy Session Narrowly Mixed

Indian shares fluctuated before ending little changed on Tuesday as investors waited for more details to emerge from the second day of ongoing U.S.-China trade negotiations in London.
RTTNews | 1 h 48 min atrás
Yen Recovers Amid BoJ Rate Hike Speculation

Yen Recovers Amid BoJ Rate Hike Speculation

The Japanese yen recovered from early lows against other major currencies in the European session on Tuesday, as traders speculate that the Bank of Japan (BoJ) will hike interest rates this year.
RTTNews | 2 h 9 min atrás
UK Jobless Rate Rises; Wage Growth Softens

UK Jobless Rate Rises; Wage Growth Softens

The UK unemployment rate rose slightly in the three months to April period and wage growth softened as the rise in social security contribution and the minimum wage started to weigh on the labor market activity. The ILO jobless rate rose to 4.6 percent in the three months to April, as expected, from 4.5 percent in the three months to March, data from the Office for National Statistics revealed T
RTTNews | 2 h 34 min atrás