Other
fda-approvals
$99/mo daily digest of new FDA drug approvals filtered by your drug
Launch kit
fda-approvals launch kit
One-liner
$99/mo daily digest of new FDA drug approvals filtered by your drug class, indication, or sponsor — Bloomberg-style intelligence at 1/240th the cost.
Buyers
- Hedge fund analysts running biotech long/short books — $999/mo Firm tier
- Pharma BD/licensing teams — $299/mo Pro tier
- Specialty pharmacies tracking generic launches — $99/mo Watcher
- Patent attorneys watching for prior-art on competitor approvals — $99
- Biotech consultants monitoring competitive landscape — $299
Pain
- openFDA's API is undiscoverable and undocumented for non-engineers
- Bloomberg pharma terminal: $24K/yr/seat (way overkill for most users)
- BiopharmaCatalyst.com is generic & late
- Manual scraping consumes 1-2 hrs/day in pharma analyst workflows
- Missing a competitor approval costs deals/positions
Differentiator
- Per-user filters (drug class, sponsor, indication) — not generic
- Same-day notification (cron pulls 1am ET, openFDA latency ~4hrs)
- Plain-English summaries (Claude reads the SBA + label) at Pro tier
- API access for programmatic users at Pro/Firm
Positioning
"Bloomberg-grade pharma intelligence for the cost of a Substack."
Distribution
- LinkedIn ads: "biotech analyst" / "pharma intelligence" / "specialty pharmacy"
- Quora: pharma-investing answers with link in bio
- /r/biotech, /r/Investing, /r/pharma posts
- Free-tier with 1 filter to drive trial
Risks
- openFDA rate limits (we cache; minor risk)
- A scoop-grade competitor (Endpoints, FierceBiotech) — they're paywalled and broader; we're machine-friendly and cheap
- License risk: openFDA is public-domain so no licensing concern
Documentation
fda-approvals — daily FDA drug-approval intelligence
Pharma-adjacent companies, hedge funds, and biotech consultants need to know about new FDA approvals the day they happen. Most relevant new approvals get a 30-day window of trading/positioning before the news is fully priced in.
What you get
For each subscriber, daily 7am ET email digest of new FDA approvals matching their filters (drug class, indication area, manufacturer, NDA/BLA type). Plus a queryable API for historical filter-and-pull.
Pricing
| Tier | Price | Features |
|---|---|---|
| Watcher | $99/mo | Daily digest, 3 saved filters |
| Pro | $299/mo | Daily + intra-day alerts, 10 saved filters, API access (1k calls/mo) |
| Firm | $999/mo | All Pro + per-team distribution, 20 saved filters, 10k API calls/mo |
Why this exists
- openFDA is free but undiscoverable, with a 4-hour ingest lag and inconsistent metadata
- Bloomberg's pharma terminal is $24K/yr per seat — overkill for most hedgies / biotech analysts / patent attorneys / pharma BD
- Sub-$1K/mo pharma intelligence has zero good options
- Claude does the document parsing + summarization much faster than BioPharma Catalyst-style sites
What's covered
- New Drug Applications (NDAs)
- Biologic License Applications (BLAs)
- Abbreviated NDAs (generic approvals)
- Supplemental NDAs (label expansions)
- Drug Approval Process status changes
- Adverse-event signal flags (per drug class)
How filtering works
When subscribing, you set filters across:
- Drug class (e.g. GLP-1, BTKi, mAbs, gene therapy)
- Indication (e.g. type-2 diabetes, NSCLC, AD)
- Manufacturer (e.g. Pfizer, Lilly, BMS)
- Approval type (NDA, BLA, sNDA, ANDA)
- Priority review flag
- Breakthrough designation flag
Filters use OR-within-field, AND-across-fields. You can save up to your plan's filter cap.
Sample email digest
=== fda-approvals daily — 2026-04-30 ===
📋 3 approvals matching your filters
[1] tirzepatide (Eli Lilly) — type-2 diabetes
- sNDA: label expansion to chronic kidney disease in T2D
- Approval date: 2026-04-29
- Notes: Priority review; cardiorenal trial data submitted
[2] obecabtagene autoleucel (BMS / Bristol Myers Squibb) — relapsed/refractory ALL
- BLA approval; first BCMA-targeted CAR-T for adult ALL
- Boxed warning for cytokine release syndrome
- Notes: Outcomes/REMS program required
[3] BMN-307 (BioMarin) — phenylketonuria
- Original NDA approval
- First gene-therapy approval for PKU
- Notes: Single-dose administration; complete-response rate 78%
Architecture
- Daily cron (1am ET) pulls openFDA approvals API
- Records that match any filter trigger an email job
- Email goes via Resend; structured-data CSV available via API
- Historical store in SQLite (per-subscriber filter results retained 90 days; full corpus retained indefinitely)
API
GET /v1/approvals?since=2026-04-01&drug_class=GLP-1&limit=50
Authorization: Bearer ock_...
200 OK
{
"count": 4,
"approvals": [{...}, {...}, ...]
}