{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-23-057341","form_type":"8-K","ticker":"ADMA","cik":"0001368514","company_name":"ADMA BIOLOGICS, INC.","filed_at":"2023-12-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.773467+00:00","generated_at":"2026-06-07T14:04:37.429560+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA approves ADMA's BIVIGAM for pediatric PI patients aged 2 and older","bullets":["FDA approved supplemental BLA for BIVIGAM to treat primary humoral immunodeficiency (PI) in patients 2 years and older.","Prior indication restricted to PI patients aged 12 years and older; label expansion opens new pediatric segment.","Approval fulfills post-marketing commitment from original BLA; final pediatric study report completed.","CEO Adam Grossman stated expanded label allows treating younger PI patients earlier in their treatment journey.","ADMA will offer BIVIGAM as an FDA-approved option for pediatric PI patients aged 2+ immediately."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-23-057341","json":"https://secwatch.observer/filing/0001140361-23-057341.json","markdown":"https://secwatch.observer/filing/0001140361-23-057341.md","text":"https://secwatch.observer/filing/0001140361-23-057341.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1368514/000114036123057341/0001140361-23-057341-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1368514/000114036123057341/ef20016477_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T14:04:37.429560+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"}