A comprehensive view of New Drug/Biologic License Application (NDA/BLA). This page highlights a small sample of our full coverage.
For real-time access, please log in to your R&D/Patents Market Intelligence Service.

Recent Articles

sample of recent headlines, press releases and get more..

Regeneron reports FDA has accepted its sBLA for Evkeeza evinacumab-dgnb for priority review; Evkeeza treats children with ultra-rare inherited homozygous familial hypercholesterolemia, a form of high cholesterol

Teva re-submits NDA to FDA for mdc-IRM, a risperidone subcutaneous injectable for maintenance treatment of schizophrenia; drug is delivered using MedinCell’s proprietary long-acting injectable technology

FDA accepts for priority review Gilead's sBLA for Trodelvy injectable for pre-treated HR+/HER2- metastatic breast cancer; sBLA based on Phase 3 data, which met its primary endpoint for progression-free survival

BioMarin Pharmaceutical resubmits application to FDA for approval of injectable gene therapy valoctocogene roxaparvovec to treat severe hemophilia; if approved, the drug would be first commercially-available gene therapy in US to treat the condition

Moderna completes submission to the FDA requesting emergency use authorization for Omicron-targeting bivalent COVID-19 booster vaccine; application is for a booster dose in adults age 18 years and older

Ask us about our R&D/Patents market view

Trending Chart

Interactive chart with headline count