Regulatory Catalysts

Upcoming FDA advisory committee (AdCom) meeting calendar — a leading biotech regulatory catalyst. Lists FDA panel meetings announced in the Federal Register (keyless), extracting the scheduled meeting date from each notice. Covers oncology (ODAC), cellular/tissue & gene therapy (CTGTAC), and every other FDA advisory committee; captures panel-vote meetings that precede or accompany drug/biologic approval decisions (PDUFA-adjacent). Returns each meeting with committee, meeting date (ISO when parseable) plus raw date text, topic, publication date, Federal Register URL, and document number, sorted soonest-first. Use for AdCom, advisory committee, panel vote, drug approval catalyst, FDA meeting calendar, upcoming biotech panels.

What evidence is an FDA advisory committee reviewing? For one FDA advisory committee (AdCom) meeting — picked by committee (ODAC, VRBPAC, CTGTAC, or any name fragment), by date, and/or by drug, sponsor or topic — returns the meeting page's posted materials: FDA and sponsor briefing documents, the agenda, questions to the committee, rosters, presentation slides, minutes and transcripts, each with a document type, party (FDA / sponsor / combined), file type and size, and URL. Also extracts the agenda text, the applications under review (NDA/BLA number, product, sponsor, proposed indication), the public docket number, the webcast link, and — when a Questions document is posted — the VOTING QUESTIONS text itself. Reads FDA's own advisory-committee calendar (fda.gov, keyless), which lists meetings from 2016 to the next scheduled one; when a meeting has nothing posted yet it says so with the meeting date and FDA's posting timeline instead of returning an empty list. Use for AdCom briefing document, FDA briefing book, advisory committee materials, ODAC questions, what is the panel voting on, sponsor briefing package, panel agenda, FDA presentation slides, AdCom transcript or minutes. Pair with fda_adcom_calendar (which meetings are coming) and pdufa_catalysts (the decision date that follows the panel).

Companies with disclosed PDUFA dates — the highest-signal binary biotech catalyst. Searches recent SEC EDGAR 8-K filings (keyless) for PDUFA target / goal / action dates and extracts the date and surrounding context. A PDUFA date is the FDA decision date for an NDA or BLA; it is a scheduled binary event that moves biotech stocks. Returns each disclosure with company, ticker, CIK, filing date, form, PDUFA date (ISO when the filing gives a specific day), pdufa_period when the filing discloses only a coarser grain such as "Q1 2027" or "March 2027", a short context snippet, the SEC filing URL, and accession number. A row may carry a period without a date — that is the filing being vague, not a lookup failure. Use for PDUFA date, PDUFA goal date, FDA decision date, upcoming FDA decisions, drug approval catalyst, NDA/BLA decision date, biotech binary event, catalyst by ticker. ALSO the REGULATORY-STATUS reading of the same data, which is what most callers actually ask: which drugs are currently UNDER FDA REVIEW, which medicines ENTERED FDA REVIEW or were ACCEPTED FOR REVIEW recently, new NDA/BLA SUBMISSIONS and FILINGS ACCEPTED by the FDA, drugs AWAITING FDA APPROVAL, what is in the FDA review queue. A company announces acceptance in an 8-K at the moment review begins, so filing_date is when the drug ENTERED review and pdufa_date is when the decision is due — bounding filing_date with since/until answers "what entered FDA review last week". Note this is REGULATORY review of a marketing application, not clinical trials: for drugs entering or moving through TRIALS use the clinicaltrials tools instead.