Clinical research
Weeks after the FDA rejected Veru’s Emergency Use Authorization bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug.
Cambrian BioPharma announced the launch of Amplifier Therapeutics, a biotech focused on developing a clinical-stage AMPK activator.
Partners CRISPR and ViaCyte (Vertex), and Genprex are pioneers in the quest to develop a gene therapy for Type 1 diabetes.
The FDA has lifted the clinical hold it had placed on the Phase Ib study following the occurrence of hematological malignancies.
Acadia Pharmaceuticals announced the approval of Daybue (trofinetide) as the first and only drug to treat Rett Syndrome, a rare, neurodegenerative disorder affecting primarily girls.
Despite missing the initial mark, new analysis of Clene’s gold nanocrystal therapy from the HEALEY ALS trial indicates the asset still shows promise.
AstraZeneca reported positive data from both the Phase III ADAURA trial studying Tagrisso (osimertinib) and the Phase III AEGEAN studying Imfinzi (durvalumab) in NSCLC patients.
Data released Wednesday from the Phase III A4 study showed solanezumab fell short of its primary endpoint, failing to slow cognitive decline in patients with preclinical Alzheimer’s disease.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
BioMarin announced Tuesday that the FDA has accepted its supplemental New Drug Application to expand Voxzogo for children younger than five years with achondroplasia.
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