FDA Approval Alerts
Watch the FDA page and the company 8-K. Skip the delayed biotech roundup.
FDA approval alerts watch the agency page and the 8-K, so you are not waiting on a biotech newsletter.
Approvals, complete response letters, and adcomm outcomes show up on FDA pages and in company filings first. Newsletters assemble that into a digest. Digests are late on purpose. If you hold the name, you wanted the agency URL and the 8-K, not a Friday roundup with twelve other tickers.
AyeWatch watches those public pages and topics. It summarizes what the agency or the company posted. It is not a clinical-trial data terminal. It is not Bloomberg. It does not have MNPI from the agency. The page is public when it is public.
Two URLs that matter
FDA news releases and Drugs@FDA for the decision. The company IR page and the 8-K for the same event in issuer language. Watch both. One source lies by omission. Two sources still can, but you are less likely to miss the post.
PDUFA dates are calendars. Intensify the watch in the days around them. Do not confuse a target date with a decision. The alert should fire on the announcement, not on another "what to expect this week" preview.
Newsletter lag
Trade press is fine after you already know. It is a bad primary. Write the topic as "Alert me when FDA posts an approval, CRL, or safety communication in this therapeutic area, or when these issuers file an 8-K about a regulatory decision. Ignore investor-outlook recaps."
The longer biotech walkthrough is tracking FDA approvals in real time. Filing context is SEC filing monitoring. Audience page: /for/biotech.
Start a monitor in under a minute
Free Preview is six lifetime runs across three topics. No card.
Try AyeWatch freeHow to watch a PDUFA
Paste the FDA announcements URL. Paste IR for the names you hold. Name the drug or the area. Push. Free Preview is six lifetime runs across three topics. Pro is $9 a month. ASAP on Max or Ultra if you actually sit the decision.
Hold CRLs and clinical holds in the same topic if you trade the binary. Split them if you only want approvals. Noise is how these watches fail.
Honest limits
Label restrictions, REMS, and fine print live in the letter. The summary gets you to the letter faster. It does not replace it. No alert is a medical or trading recommendation. Start with one name on a known date. If the ping is the FDA page and not a blog, add the rest of the pipeline.