Akebia Therapeutics scored a long-awaited win Tuesday when it announced the FDA has granted a path forward for vadadustat in anemia associated with chronic kidney disease in dialysis-dependent patients, which will not require the company to submit new data.
Tag Archive for: New Drug Application
Findings from the ACTION-Galactosemia Kids study showed Applied Therapeutics’ govorestat fell short of its primary endpoint, inducing no significant functional improvement in children with galactosemia, a rare genetic metabolic disease.
Thursday, the FDA pushed back its target action date by three months for Daiichi Sankyo’s investigational acute myeloid leukemia (AML) drug quizartinib, citing updates to the proposed Risk Evaluation and Mitigation Strategies (REMS).
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen’s effect on neurofilament light chain could be a reasonable predictor of clinical benefit.
The rare disease biotech announced the FDA has accepted its supplemental New Drug Application to expand Voxzogo (vosoritide) to children younger than five years.
After the flurry of verdicts and meetings at the end of February, the FDA has a relatively quiet week ahead with only two stand-out events.
Biogen’s $1.5 billion bet is in the home stretch. On Monday, the Cambridge biotech, along with partner Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
To further support pharma manufacturing partners and ensure launch delays are avoided, the company has deepened its expertise with REMS Strategy and Project Management solutions.
