Biotech | May 01, 2022
Inmagene receives USFDA's IND clearance for ox40 antagonist
The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients
The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients
CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products
Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo
Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
Participants taking tirzepatide lost up to 52 lb. (24 kg) in this 72-week phase 3 study
A separate global Phase 3 study of S-217622 is underway aiming to recruit participants globally to support regulatory filings this year
The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic
Pre-exposure prevention trial reduced risk of symptomatic Covid-19, with no severe disease or Covid-19-related deaths in the Evusheld group
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC
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