BridgeBio gears up for FDA review of acoramidis following Phase III results
BridgeBio submitted the NDA with US FDA for the TTR stabiliser in December 2023 and plans to engage with other regulatory bodies this year.
11 January 2024
11 January 2024
BridgeBio submitted the NDA with US FDA for the TTR stabiliser in December 2023 and plans to engage with other regulatory bodies this year.
The trial’s primary efficacy goal is to assess the time to the first supplemental aflibercept injection up to 24 weeks.
The minimally invasive cell-based blood cancer test opened a HER2-targeted therapy option to participants, leading to improved overall survival.
The US company has completed over 300 surgeries in hopes of paving the way to the FDA premarket approval pathway.
The two companies aim to enhance decentralised clinical trials and accelerate enrolment and study timelines.
The ChAdOx1 NipahB vaccine is being developed by the University's Pandemic Sciences Institute.
The upcoming 14-day pilot study will investigate the safety and response of MP101 in patients with neurogenerative diseases.
The primary goal of the trial is to evaluate the safety and tolerability of escalating doses of BP1002.
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