FDA Approval The latest news regarding FDA applications, processes and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions and safety alerts.

Latest FDA Approval

11 Jan, 2018, 12:00 GMT Norgine Launches Lymphoseek®▼ in Finland and Sweden

Norgine B.V. today announced the launch of LYMPHOSEEK® (Tc 99m tilmanocept) in Finland and Sweden. LYMPHOSEEK® is a radiopharmaceutical used for...


10 Jan, 2018, 09:07 GMT BioProtect Launches an International Multi-Center Clinical Study Following FDA investigational Device Exemption (IDE)

FDA has granted investigational Device Exemption approval (IDE) to conduct a pivotal clinical study examining the use of the ProSpace[TM]...


04 Jan, 2018, 16:10 GMT Sight Sciences Expands Surgical Portfolio with FDA Clearance of the OMNI™ Surgical System

Simultaneously Announces Three Key Hires to Establish Commercial Leadership Team Sight Sciences, Inc., a venture-backed, commercial stage...


23 Dec, 2017, 09:00 GMT Bringing Access to Biologics

Abdi Ibrahim Remede Pharma (AIRP) is Biocon's partner in Algeria for the registration, marketing and pharmacovigilance monitoring of...