# FdaApprovalPulse: new FDA device and drug approvals as they happen **FdaApprovalPulse tracks 1,959 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), last refreshed 2026-11-03, for contract manufacturers and API suppliers, packaging, labeling and serialization vendors, pharma and medtech commercialization agencies, distributors and GPO contracting teams, and competitive-intelligence analysts. Search, filter and preview free; CSV unlocks, alerts and API access start at $4.99. Every record links to its official source.** PMA approvals and supplements for class III devices, new drug, generic (ANDA) and biologic approvals, and approved drug supplements (labeling and REMS, manufacturing/CMC, efficacy) from Drugs@FDA, with sponsor, product, type and decision date. Filter by approval type and sponsor state. **Instant Full CSV Unlock $4.99 one-time · Alerts (weekly email, billed monthly) from $9/month** Card, Apple Pay, Google Pay or Link via Stripe; refunds on request within 14 days. Get Instant Full CSV Unlock — $4.99 → [See all plans](#pricing) Long-tail intelligence feed for contract manufacturers and API suppliers, packaging, labeling and serialization vendors, pharma and medtech commercialization agencies, distributors and GPO contracting teams, and competitive-intelligence analysts LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Tue, 03 Nov 2026 05:14:00 GMT Have a key? Paste it to unlock the full CSV (up to 500 rows): Score is a heuristic estimate, not advice. ## Unlock the complete deliverable Your free search above is complete. The full CSV adds every matching row with all columns (up to 500); the free CSV has 3 (10 when you confirm your email). Tailor unlock for: My businessClient / agency auditSales / lead list Add Pro monitoring instead: Alerts (weekly email, billed monthly), $9/month, re-checks on a schedule and emails changes Unlock everything — $4.99 one-time → Card, Apple Pay, Google Pay or Link via Stripe; refunds on request within 14 days. ✓ Live public data, refreshed 2026-11-03 · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days Preview what the unlock includes - Every matching row, up to 500 (the free CSV has 3; 10 when you confirm your email) - Columns: Sponsor, Product, Approval, Decided, plus each record's source link - CSV that opens in Excel or Google Sheets and imports into a CRM Already paid? Enter your key or email to unlock Double opt-in: we email one confirmation link first; nothing else until you confirm. One-click unsubscribe. ## Top FdaApprovalPulse records - [Instylla, Inc.](/report/fdaapprovalpulse/instylla-inc-bedford-ma--pma-p250003-s008) - [Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)](/report/fdaapprovalpulse/ventana-medical-systems-inc-roche-tissue-diagnostics-tucson-az--pma-p240037-s003) - [Cerenovus, Inc.](/report/fdaapprovalpulse/cerenovus-inc-miami-fl--pma-p990040-s037) - [Advanced Medical Solutions Limited](/report/fdaapprovalpulse/advanced-medical-solutions-limited-plymouth--pma-p220024-s007) - [Lenstec, Inc.](/report/fdaapprovalpulse/lenstec-inc-st-petersburg-fl--pma-p200020-s013) ## Latest top-scored records | Record | Product | Approval | Decided | |---|---|---|---| | AMGEN INC | PAVBLU | Biologic license (BLA) | 2026-10-22 | | SANDOZ INC | ENZEEVU | Biologic license (BLA) | 2026-10-22 | | GLAXOSMITHKLINE LLC | HIBSAGO | New drug application (NDA) | 2026-10-20 | | FRESENIUS MEDCL CARE | CIENBY | New drug application (NDA) | 2026-10-19 | | FRESENIUS MEDCL CARE | CALREZDY | New drug application (NDA) | 2026-10-19 | ### Browse by approval type [Drug labeling or REMS supplement (1174)](/hub/fdaapprovalpulse/type/suppl-labeling) [PMA supplement (device change) (367)](/hub/fdaapprovalpulse/type/pma-supplement) [Generic drug approval (ANDA) (194)](/hub/fdaapprovalpulse/type/anda) [Drug efficacy supplement (new indication or use) (76)](/hub/fdaapprovalpulse/type/suppl-efficacy) [Drug manufacturing (CMC) supplement (55)](/hub/fdaapprovalpulse/type/suppl-manufacturing) [New drug application (NDA) (40)](/hub/fdaapprovalpulse/type/nda) [PMA original approval (new class III device) (24)](/hub/fdaapprovalpulse/type/pma-original) [Biologic license (BLA) (17)](/hub/fdaapprovalpulse/type/bla) [Other drug supplement (12)](/hub/fdaapprovalpulse/type/suppl-other) ### Browse by sponsor state (devices) [California (110)](/hub/fdaapprovalpulse/state/ca) [Minnesota (61)](/hub/fdaapprovalpulse/state/mn) [Massachusetts (37)](/hub/fdaapprovalpulse/state/ma) [Oregon (20)](/hub/fdaapprovalpulse/state/or) [Arizona (18)](/hub/fdaapprovalpulse/state/az) [Texas (18)](/hub/fdaapprovalpulse/state/tx) [Illinois (9)](/hub/fdaapprovalpulse/state/il) [Maryland (9)](/hub/fdaapprovalpulse/state/md) [Tennessee (8)](/hub/fdaapprovalpulse/state/tn) [Pennsylvania (7)](/hub/fdaapprovalpulse/state/pa) [Florida (6)](/hub/fdaapprovalpulse/state/fl) [Washington (6)](/hub/fdaapprovalpulse/state/wa) [Missouri (5)](/hub/fdaapprovalpulse/state/mo) [Wisconsin (5)](/hub/fdaapprovalpulse/state/wi) [Colorado (4)](/hub/fdaapprovalpulse/state/co) [Connecticut (4)](/hub/fdaapprovalpulse/state/ct) [Georgia (4)](/hub/fdaapprovalpulse/state/ga) [Indiana (4)](/hub/fdaapprovalpulse/state/in) [New Jersey (4)](/hub/fdaapprovalpulse/state/nj) [New York (4)](/hub/fdaapprovalpulse/state/ny) [North Carolina (3)](/hub/fdaapprovalpulse/state/nc) [Ohio (3)](/hub/fdaapprovalpulse/state/oh) [All FdaApprovalPulse hubs](/hub/fdaapprovalpulse) · [RSS feed](/feed/fdaapprovalpulse.xml) ## Get new FdaApprovalPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdaapprovalpulse) ## Plans Monthly Yearly ### Instant Full CSV Unlock $4.99 one-time - One-time $4.99: full CSV of your current search (up to 500 rows instead of the free 3-row sample) - Unlocked instantly with your key; yours to keep Get Instant Full CSV Unlock — $4.99 → ### Alerts (weekly email, billed monthly) $9 / month ($0.30/day) - A weekly email of new records matching your filters, billed monthly; cancel any time Start Alerts (weekly email, billed monthly) → ### Pro Feed + API $49 / month ($1.61/day) - Daily alerts for up to 10 saved filters. Billed monthly (or yearly at the annual price); cancel any time - Full CSV export any time - REST and MCP API access Start Pro Feed + API → ## More ways to buy ### 500 API / MCP Credits $9.99 one-time - 500 full (unredacted) REST or MCP calls across every product - Credits never expire Buy now ### Unlimited API / MCP Key $29 / month - Unlimited full REST and MCP calls across every product. Billed monthly (or yearly at the annual price); cancel any time - For Make, Zapier, n8n and AI agents Subscribe ### Full Dataset Snapshot $49.00 one-time - One-time download of every real record we hold for this product as CSV - Cleaned, deduplicated, with source links Buy now API: 10 free calls per day without a key. Datasets contain public records only, at organization level. Payments are processed securely by Stripe. Refunds are available by default within the first 14 days of paid service. [Free weekly digest](/digest/fdaapprovalpulse) · [Embed this feed on your site](/embed) · [RSS](/feed/fdaapprovalpulse.xml) From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval. ## Often used together - [FDAPulse](/v/fdapulse) - [FdaNdcDirectoryPulse](/v/fdandcdirectorypulse) - [NycPropertyExemptionDetailPulse](/v/nycpropertyexemptiondetailpulse) - [MigrationRedirectAudit](/migrationredirectaudit) - [SchemaMarkupGeneratorKit](/schemageneratorkit) - [ShopifyStorefrontXray](/shopifystorefrontxray)