Shots:
The FDA issued a complete response letter for the ONS-5010/LYTENAVA™ BLA resubmission, declining approval for wet AMD in its current form
The ONS-5010 BLA resubmission was based on full NORSE trial data, including the pivotal NORSE TWO and confirmatory studies like NORSE EIGHT, a study evaluating ONS-5010 vs ranibizumab in a 12-wk trial of…
Shots:
Mabwell’s Adalimumab Injection 9MW0113 (marketed as JUNMAIKANG in China), a Humira biosimilar, has received marketing authorization from Indonesia’s BPOM
Adalimumab Injection 9MW0113, co-developed by Mabwell and Junshi Biosciences. Mabwell has submitted registration applications in multiple countries, including Jordan and Peru, and has agreements in over ten markets
Adalimumab is a TNF blocker, binds TNF‑alpha…

