The U.S. Food and Drug Administration (FDA) has cleared the first ever biodegradable subacromial balloon spacer developed by OrthoSpace Inc. and acquired by Stryker. The balloon, called InSpace, is the first implant for arthroscopic treatment of MIRCTs (massive...
The U.S. Food and Drug Administration (FDA) has accepted Enochian BioSciences Pre-IND (Investigational New Drug) request for a potential cure of Hepatitis B (HBV). HBV is a viral infection that affects the liver. The request comes after promising results from a...
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,...
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...
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