MRNA - Moderna Scores FDA Approval For Its Second Product - Respiratory Syncytial Virus Vaccine | Benzinga
On Friday, the FDA approved Moderna Inc’s (NASDAQ:MRNA) mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection.
The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna, the first being the famed COVID-19 vaccine.
Earlier this month, the FDA, citing administrative constraints, delayed the review of the vaccine’s application.
“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA ...