Anivive Awarded FDA Grant for Canine Cancer Research
The U.S. Food and Drug Administration (FDA) has awarded Anivive, a pet health tech company, a $500,000 USD grant to continue research on LAVERDIA™ -CA1 (verdinexor) and its effect on treating canine cancer. As one of four companies selected for the MUMS grant,...
AstraZeneca-Amgen Asthma Treatment Granted FDA Speedy Review
A drug by AstraZeneca and Amgen designed to treat asthma has been granted a speedy review by the Food and Drug Administration (FDA). The experimental drug tezepelumab aims to reduce asthma attacks for patients with severe and uncontrolled forms of asthma. Both...
UDI Guidance Finalized by FDA
The U.S. Food and Drug Administration (FDA) has finalized UDI guidance content requirements and form for unique device identifiers (UDIs), after five years from its first drafted release. The guidance covers two types of UDIs, including automatic identification and...
ANSEM Grants Cohort Temporary Authorization for Use to GenSight Biologics
ANSEM (the National Agency for Medicines and Health Products Safety), France's Competent Authority, has granted Cohort Temporary Authorization for Use (ATUc) to GenSight Biologic's LUMEVOQ®. LUMEVOQ® is a drug therapy designed to treat Leber Hereditary Optic...
Delta Variant: J&J COVID-19 Vaccine Shows Promising Results
Johnson & Johnson have announced that findings from a laboratory study have shown promising results for it its single-dose COVID-19 vaccine against the Delta variant. Blood analysis drawn from eight patients revealed that immune responses to the Delta variant were...
FDA Approves HDT Bio COVID-19 Vaccine Phase 1 Clinical Trial
The FDA (Food and Drug Administration) has evaluated HDT Bio Corp’s Investigational New Drug (IND) Application and given the company the green light for a Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT Bio, a developer of immunotherapies for oncology...
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