ADMA Biologics Secures FDA Approval For BIVIGAM In The Pediatric Patient Setting For Those 2 Years Of Age And Older
Portfolio Pulse from Benzinga Newsdesk
ADMA Biologics has received FDA approval for BIVIGAM to be used in pediatric patients aged 2 years and older for primary humoral immunodeficiency (PI). This approval fulfills the post-marketing commitment and allows for an update to BIVIGAM's prescribing information to include this new pediatric indication.
December 12, 2023 | 12:02 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
ADMA Biologics' BIVIGAM has been approved by the FDA for use in children 2 years and older with primary humoral immunodeficiency, potentially increasing the drug's market and usage.
The FDA approval for pediatric use of BIVIGAM is a significant milestone for ADMA Biologics, likely leading to increased demand for the treatment and potentially boosting the company's revenue. The news is directly related to ADMA's product offering and is important for investors as it could impact the company's financial performance and market position in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100