Biotech Catalyst Tracker: FDA & MHRA Approvals, Clinical Trials, AdComs and CRLs

One clean feed of biotech and pharma catalysts from official public sources. Get new FDA drug approvals, complete response letters (CRLs), FDA approval press releases, upcoming FDA advisory committee (AdComm) meetings, MHRA UK marketing authorisations and ClinicalTrials.gov results and status changes in a single normalised dataset. Filter by company or sponsor and by condition, and get tickers for major listed pharma and biotech companies.

• Official data only: openFDA, FDA.gov, GOV.UK (MHRA) and the ClinicalTrials.gov API v2. No logins, no paid data, no proxies.
• One schema for every source: eventType, date, company, product, indication, phase, status, summary, sourceName, sourceUrl, ticker.
• Monitoring mode: turn on onlyNew, schedule it daily, and get only catalysts you have not seen before. Trial status changes are detected between runs.
• Lean and cheap: plain API calls at 256 MB, with a typical run under 3 minutes.

Disclaimer: This actor provides data only. It is not investment, medical or regulatory advice. Check every item against the linked official source before you act on it. The data is provided as published by each source, which can contain errors, delays or later corrections.

What you get

eventType	Source	What it means
fda_approval	Drugs@FDA via openFDA	Original NDA or BLA approval (new drug, new dosage form or new formulation)
fda_new_indication_approval	Drugs@FDA via openFDA	Efficacy supplement approved (usually a new indication or population)
fda_tentative_approval	Drugs@FDA via openFDA	Tentative approval
fda_complete_response_letter	openFDA CRL dataset	FDA complete response letter (application not approved), with a link to the published letter
fda_approval_press_release	FDA press announcements RSS	FDA's own approval announcements, with product, indication and the company the approval was granted to
fda_advisory_committee_meeting	FDA advisory committee calendar	Upcoming and recent drug and biologic AdComm meetings, with the application, product, sponsor and proposed indication from the agenda
mhra_new_medicine_authorisation	MHRA press releases on GOV.UK	New UK medicine authorisations announced by the MHRA, with indication, licence holder and route (for example the International Recognition Procedure)
mhra_marketing_authorisation	MHRA "Marketing authorisations granted" lists on GOV.UK	Every UK product licence (PL) granted, with holder, product, active ingredient and legal status
trial_results_posted	ClinicalTrials.gov API v2	Results first posted for a study
trial_status_update	ClinicalTrials.gov API v2	Study updated with a key status: completed, terminated, suspended, withdrawn or active not recruiting
trial_registered	ClinicalTrials.gov API v2	Newly registered study (optional)

Real sample from a test run on 23 Oct 2026 (lookback 7 days)

eventType	date	company	ticker	product	indication / status
fda_approval_press_release	20 Oct 2026	GSK plc	GSK	Hibsago (bepirovirsen)	chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis
fda_new_indication_approval	19 Oct 2026	GlaxoSmithKline	GSK	dostarlimab (Jemperli)	efficacy supplement, priority review
fda_new_indication_approval	16 Oct 2026	Merck Sharp Dohme	MRK	KEYTRUDA QLEX	efficacy supplement
fda_approval	19 Oct 2026	Fresenius Medical Care		CALREZDY	Type 2, new active ingredient
fda_advisory_committee_meeting	30 Oct 2026	Sydnexis		atropine sulfate ophthalmic solution 0.01%	slowing of myopia progression in children 3 years of age or older (upcoming)
fda_complete_response_letter	7 Aug 2026	ITM Solucin GmbH		NDA 218705, lutetium Lu177 edotreotide injection	complete response
mhra_new_medicine_authorisation	19 Oct 2026	Arrowhead Pharmaceuticals Ireland Limited	ARWR	plozasiran (Redemplo)	familial chylomicronaemia syndrome
mhra_marketing_authorisation	13 Oct 2026	Eli Lilly Nederland B.V.	LLY	Onswik 500 units/ml KwikPen	granted
trial_results_posted	22 Oct 2026	Merck Sharp & Dohme LLC	MRK	pembrolizumab + chemotherapy	triple negative breast neoplasms, Phase 3
trial_status_update	22 Oct 2026	Sanofi	SNY	balinatunfib	ulcerative colitis, Crohn's disease, Phase 2, TERMINATED

Sample item (JSON)

{"eventType": "mhra_new_medicine_authorisation", "date": "2026-10-19", "company": "Arrowhead Pharmaceuticals Ireland Limited",
 "product": "plozasiran (Redemplo)", "indication": "familial chylomicronaemia syndrome", "phase": "", "status": "Authorised",
 "summary": "MHRA authorises plozasiran (Redemplo) for adults with familial chylomicronaemia syndrome. ... Route: International Recognition Procedure (IRP), Route B, with the European Medicines Agency (EMA) as the reference regulator.",
 "sourceName": "MHRA press releases (GOV.UK)", "sourceUrl": "https://www.gov.uk/government/news/mhra-authorises-plozasiran-redemplo-for-adults-with-familial-chylomicronaemia-syndrome",
 "ticker": "ARWR", "source": "mhra_press", "regulator": "MHRA", "recordId": "mhra:/government/news/mhra-authorises-plozasiran-redemplo-for-adults-with-familial-chylomicronaemia-syndrome"}

Use cases

• Biotech investors' research: a daily list of FDA approvals, CRLs, AdComm dates and late stage trial readouts, tagged with tickers, to feed your own research process.
• Pharma business development and competitive intelligence: follow competitors' approvals in the US and the UK, trials that complete or are terminated, and new registrations in your therapy area.
• Journalists and newsletter writers: a factual, sourced feed of regulatory decisions and trial events, with a link to the official record on every row.
• Healthcare and market access analysts: track UK licences (MHRA) next to US approvals, and check uptake later with our UK NHS Prescribing Data actor (GP prescribing by drug, ICB and practice across all four UK nations).

Pair it with NHS prescribing data: when a drug gets an MHRA authorisation in this feed, run the NHS prescribing actor on the same molecule a few months later to see real world UK uptake by area.

Input

Field	What it does	Default
Sources	Any of fda_approvals, fda_crl, fda_press, fda_adcomm, mhra_press, mhra_ma_list, clinical_trials	all
Lookback days	Window for approvals, press releases, grants and trial updates	7
Company or sponsor filter	For example Novo Nordisk, Lilly, AstraZeneca. Sent to ClinicalTrials.gov as a sponsor search	none
Condition keywords	For example obesity, Alzheimer. ClinicalTrials.gov uses its own condition search with synonyms	none
Max rows / max rows per source	Caps. Sources are interleaved so a cap keeps a fair mix	200 / 50
Only new (monitoring)	Return only rows not returned before for this monitor name	off
FDA approval scope	Originals and efficacy supplements, all NDA/BLA actions, or everything including generics (ANDA)	originals and efficacy
CRL lookback days	openFDA publishes CRLs in batches, so CRLs use a longer window	90
Trial events, phases, sponsor type	Results posted and status updates; Phase 2 and 3; industry sponsors	as shown
Advisory committees, days ahead	Drugs and biologics only, or all centres; how far ahead	CDER and CBER, 120 days
FDA detail pages	AdComm agendas and press pages opened for product, sponsor and indication (about 30 s each, see notes)	4
MHRA lists: skip likely generics	Drop list rows whose name starts with the active ingredient	off

Example: daily obesity and diabetes monitor

{"lookbackDays": 2, "conditions": ["obesity", "diabetes", "weight"], "onlyNew": true, "monitorName": "metabolic"}

Example: big pharma watchlist, FDA and MHRA only

{"sources": ["fda_approvals", "fda_press", "fda_crl", "mhra_press", "mhra_ma_list"], "companies": ["Novo Nordisk", "Lilly", "AstraZeneca", "GSK", "Pfizer", "Moderna"], "lookbackDays": 30}

Example: Phase 3 readouts by oncology sponsors

{"sources": ["clinical_trials"], "trialPhases": ["PHASE3"], "trialEvents": ["results_posted", "status_update"], "conditions": ["cancer", "carcinoma", "lymphoma"], "lookbackDays": 7}

Pricing (pay per event)

Event	Price	Per 1,000
event-row: one catalyst row in the dataset	$0.003	$3 per 1,000 rows

Examples: the default run (all sources, 7 days, 50 rows per source) returns about 100 to 200 rows, so about $0.30 to $0.60. A daily onlyNew monitor with a company or condition filter usually returns a handful of rows, a few cents a day. The RUN_SUMMARY record carries no charge.

Data sources and terms

Source	Access	Notes
openFDA Drugs@FDA and drug label	Public API, no key needed	Indication comes from the current label when it is indexed (new approvals often are not yet)
openFDA complete response letters	Public API	Published in batches, weeks or months after the letter date
FDA press announcements RSS	Public RSS	Only approval related items are kept
FDA advisory committee calendar	Public page data	Detail pages are opened at the 30 second pace that fda.gov's robots.txt asks for
GOV.UK search and content APIs (MHRA)	Public API	Contains public sector information licensed under the Open Government Licence v3.0
ClinicalTrials.gov API v2	Public API	Requests are spaced to stay under the documented fair use rate

openFDA data is provided by the US FDA, which notes that it is unvalidated and must not be used for medical decisions. This actor is independent and is not affiliated with or endorsed by the FDA, the MHRA, the NIH/NLM or any company listed.

Not included, and why

• PDUFA goal dates: the FDA does not publish PDUFA dates, and the sites that compile them from company announcements are paywalled or do not allow automated reuse. There is no open, permitted, reliable source, so the actor includes the FDA advisory committee calendar instead. AdComm meetings are usually the clearest public signal of an upcoming FDA decision.
• London Stock Exchange RNS: RNS is a licensed news service with no open public feed or API, so it is not included.

Notes and known limits

• Dates: FDA approvals use the action date, CRLs the letter date, MHRA rows the grant or publication date, and trials the ClinicalTrials.gov posting date.
• MHRA lists come out every two weeks and lag grants by about a week. When a new list is published inside your window, all its rows are included, even if the grant date is a little older.
• "Status update" is not a full status history. ClinicalTrials.gov's public API does not expose the previous status. In onlyNew mode the actor remembers each trial's status, so later runs add statusChangedFrom.
• Tickers come from a small built in map of major listed pharma and biotech companies (for example NVO, LLY, AZN, GSK, PFE, MRNA, MRK, RHHBY). Other companies are left blank. Subsidiaries are mapped where the link is clear (for example Genentech to Roche, Alexion to AstraZeneca, Kite to Gilead).
• Company names are as filed (for example "MERCK SHARP DOHME" in Drugs@FDA). The company filter is a simple case insensitive text match, so use short names like Merck or Lilly.

FAQ

Is this investment advice? No. It is a data feed of public regulatory and clinical trial records. Do your own research.

How do I get alerts? Turn on onlyNew, set a monitorName, schedule the actor daily, and connect a webhook, Slack, email or Google Sheets integration in Apify.

Can I track one company? Yes. Put its name in the company filter. For trials it searches the lead sponsor; for FDA and MHRA rows it matches the applicant or holder name and the summary text.

Does it cover the EMA? Not yet. MHRA rows often show when a UK licence used the EMA as the reference regulator.

Keywords: biotech catalyst tracker, FDA approvals API, PDUFA alternative, FDA advisory committee calendar, complete response letter, CRL tracker, openFDA, Drugs@FDA, MHRA marketing authorisations, UK drug approvals, ClinicalTrials.gov API, clinical trial results, trial terminated, pharma competitive intelligence, biotech stock research data.