{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-018667","form_type":"8-K","ticker":"ADMA","cik":"0001368514","company_name":"ADMA BIOLOGICS, INC.","filed_at":"2026-05-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.197654+00:00","generated_at":"2026-05-14T23:51:04.212119+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.78,"calibrated_materiality_score":0.78,"confidence":"high","headline":"ADMA Biologics receives FDA approval to expand ASCENIV label to pediatric patients 2 years+","bullets":["FDA approved label expansion for ASCENIV to include pediatric primary humoral immunodeficiency patients aged 2 years and older.","Previously approved only for patients 12 years and older; approval fulfills post-marketing pediatric assessment commitment.","CEO Adam Grossman: expanded label allows addressing treatment needs of younger PI patients earlier in their treatment journey.","COO Kaitlin Kestenberg highlighted collaboration with PI community and families; approval reflects strong clinical execution."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-018667","json":"https://secwatch.observer/filing/0001140361-26-018667.json","markdown":"https://secwatch.observer/filing/0001140361-26-018667.md","text":"https://secwatch.observer/filing/0001140361-26-018667.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1368514/000114036126018667/0001140361-26-018667-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1368514/000114036126018667/ef20072196_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-14T23:51:04.212119+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}