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...
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 (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...
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...
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...
With an aim to transform disruptive spine surgery, NuVasive (NASDAQ: NUVA), a leader in spine technology innovation, announced that clinical evaluations have started for its Pulse® platform which recently received CE Mark (Conformitè Europëenne) approval. The Pulse...
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