Food and Drug Administration (FDA)
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If approved, etranacogene dezaparvovec would be the first gene therapy treatment for hemophilia B.
Caladrius Biosciences announced it was suspending enrollment in its Phase IIb FREEDOM study assessing xowna for coronary microvascular dysfunction (CMD) due to supply chain issues.
Imugene and City of Hope announced that the first patient has begun treatment in a Phase I clinical trial, investigating the safety and efficacy of CF33-hNIS in adults with metastatic or advanced tumors.
The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.
Biohaven Pharma’s NDA for its nasal spray zavegepant was accepted by the FDA, while Phase III results for its drug troriluzole to treat spinocerebellar ataxia were disappointing.
Lifting the clinical hold will allow Ocugen to continue to assess the vaccine in its ongoing study and potentially support its efforts to achieve EUA or full approval.
Regeneron Pharmaceuticals shared positive results from its Phase III trial of an evinacumab for children with homozygous familial hypercholesterolemia.
Vir Biotechnology terminated a two-year-old COVID-19-related antibody collaboration with Wuxi Biologics that included sotrovimab, which lost EUA in the U.S. earlier this year.
Sunday night, U.S. health authorities announced that they may have found the third documented case of monkeypox in a patient in South Florida.
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