FDA decisions that move biotech — the second they're posted.
Approvals, complete response letters, label expansions, black-box warnings, AdComm outcomes, and 483s. Scored for catalyst impact and pushed to your phone before STAT, BioCentury, or your terminal feed has them.
See pricing →No noise. Material FDA actions only. Cancel anytime.
What you get
New drug approvals
NDA, BLA, and 510(k) clearances. Brand name, sponsor, indication, the moment the FDA action posts.
Complete response letters
CRLs detected via 8-K disclosures and Drugs@FDA timestamp changes — often the most actionable biotech catalyst.
Label changes
Black-box warnings, expanded indications, supplemental approvals, and contraindication updates.
AdComm outcomes
Advisory committee meeting calendars and post-meeting voting results.
Safety + enforcement
FDA safety communications, drug shortages, recalls, warning letters, and 483 inspection observations.
Catalyst scoring
Each event gets a 0–100 importance score. Filter by score, sponsor ticker, or indication.
Pricing
One tier. Cancel anytime.
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FAQ
openFDA APIs polled at the rate ceiling — usually under 60 seconds from posting. Drugs@FDA timestamp changes detected via diff scanning.
Pharmacy (catalystwire.org) covers ClinicalTrials.gov by disease. Catalyst Wire FDA focuses on regulatory decisions only — leaner signal.
No. Catalyst Wire is a regulatory-monitoring tool. Always do your own research; consult a licensed advisor before trading biotech.
Yes — managed by Stripe. Cancel from the email receipt's billing portal at any time.