@pipeworx/regulatory-catalysts

Connect: https://pipeworx.io/mcp — every tool in the catalog, including @pipeworx/regulatory-catalysts’s. Install: one-click buttons

No MCP client? Skip the connection: POST https://gateway.pipeworx.io/v1/tools/search_packs {"query":"..."} to find a tool below, GET /v1/tools/<name> for its schema, POST the same URL with arguments for the data — see For AI agents.

Tools: 3

Keyless biotech regulatory catalysts: FDA advisory-committee (AdCom) meetings, the evidence those panels review, and disclosed PDUFA decision dates.

fda_adcom_materials (fleet #2793)

Pick a meeting by committee (acronym or name fragment: ODAC, VRBPAC, CTGTAC, oncologic, gene therap…), date (2026-04-30, 2026-04 or 2026), and/or query (drug, sponsor, application or topic). With no filters it returns the meeting nearest to today. limit (1–3) returns more than one meeting; include_questions_text: false skips the questions-PDF fetch.

How a query is resolved, in order, with matched_by saying which won:

1. title — the calendar’s meeting titles (they name the committee, rarely a drug).
2. federal_register — the Federal Register notice that announced the meeting names the application and the drug; one full-text search plus up to three notice bodies yields the meeting date(s), which select the calendar row.
3. agenda — the 20 meetings nearest to today are opened and their page text searched. Last resort, bounded.

Each meeting carries: committee, center, meeting_date, time, the page url, page_updated, the public docket (+ regulations.gov URL), webcast_url, the agenda text, and applications parsed from the agenda (NDA 220359, product, sponsor, proposed indication). Then either:

• materials_status: "posted" with materials_count, materials_by_type, the materials list (title, document_type, party, file, media_id, url), and voting_questions — the Questions PDF’s text and its numbered items with a vote flag — when FDA has posted a Questions document; or
• materials_status: "none_posted" with materials_count: 0 and a materials_note carrying the meeting date and FDA’s posting timeline. There is deliberately no materials: [] here: nothing posted yet is a statement about the meeting, not an empty search result.

document_type is one of briefing_document, agenda, questions, roster, presentations, minutes, transcript, webcast_information, federal_register_notice, summary, public_comments, other. party is fda / sponsor / combined only when the title says so, otherwise null — CDC, academic and patient-group decks sit on the same pages and a guessed “sponsor” would read as a fact.

What FDA does not publish, so neither do we

• Per-document posting dates. The page’s own “content current as of” stamp is returned as materials_as_of; it is the closest honest answer.
• The vote tally. It is in the minutes and the transcript, which are linked, not in any structured field on the page.

Source and failure policy

• Calendar: https://www.fda.gov/datatables-json/advisory-committee-calendar-json — the JSON route behind the calendar page’s DataTable (found in the page’s own JS bundle; the page itself renders no rows server-side). One row per meeting, 2016 → the furthest scheduled meeting, ~130 KB, cached at the edge for an hour.
• Meeting pages and /media/<id>/download PDFs on www.fda.gov.
• Edge-probed 2026-10-07 with a throwaway wrangler dev --remote Worker on the prod account: the calendar JSON, two meeting pages and a 126 KB questions PDF all answered 200 with this pack’s UA. The Orange Book refusal recorded in mcps/fda-drug-competition is specific to the bulk asset route; the small per-meeting PDFs here served from the edge.
• A non-2xx from any of these, a calendar body that is not a non-empty JSON list, a meeting URL that serves fda.gov’s “FDA Internet Site Error” apology page, or an Event Materials table whose rows no longer parse is a loud { error } naming the upstream status and the page — never found: false, never an empty list. The questions-PDF step is the one best-effort part: its failure is reported in-band as voting_questions.extraction_error, beside the document’s URL, so the rest of the answer stands. src/index.test.ts pins each of these.
• found: false is reserved for filters that genuinely match no meeting, and carries the calendar’s size and date range so a caller can tell “not held” from “not in the window”.

Smoke, 2026-10-07 (laptop, esbuild bundle of this file): {committee:"ODAC"} → April 30, 2026 ODAC, 16 materials (4 briefing documents, 4 presentation decks, 2 transcripts, minutes, agenda, questions, 2 rosters, webcast), 2 applications (NDA 220359 camizestrant, sNDA 218197/S-004 capivasertib, both AstraZeneca), 2 VOTE questions extracted; {query:"camizestrant"} → the same meeting via federal_register; {committee:"microbiology devices", date:"2026-11-19"} → none_posted with the date; {committee:"VRBPAC"} → October 1, 2026, 9 materials, the strain-selection voting question.

Tools

• fda_adcom_calendar — 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
• pdufa_catalysts — 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 surr
• fda_adcom_materials — 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, sponso