Stealth faces another hurdle as FDA delays decision on Barth syndrome drug
The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
24 January 2025
24 January 2025
The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
Disc Medicine finalised the pivotal Phase III trial design of bitopertin in erythropoietic protoporphyria (EPP) with the FDA earlier this week.
The company reported a 10% annual revenue increase to $849m between Q3 2023 and Q3 2024.
Neomorph could earn up to $1.64bn from AbbVie in option fees and milestone payments.
The centre will focus on developing complex drug delivery systems such as sustained-release formulations.
ZL-1310 is being assessed both as a single agent and in conjunction with atezolizumab for treating ES-SCLC.
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