- [Home](/) › - [FdaApprovalPulse](/v/fdaapprovalpulse) › - [Hubs](/hub/fdaapprovalpulse) › - New drug application (NDA) # FdaApprovalPulse: New drug application (NDA) **40 fdaApprovalPulse: New drug application (NDA) are listed from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-01 to 2026-10-20; the most frequent is FRESENIUS MEDCL CARE with 2. Data last updated 2026-11-03; each record links to its official source and a full report.** Data as of 2026-11-03 · [Compiled by Zalwin](/research/fdaapprovalpulse) from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) Copy citation Download all 40 fdaApprovalPulse: New drug application (NDA) (CSV) — $4.99 → Includes: Sponsor, Product, Approval, Decided, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdaapprovalpulse/records.csv?type=nda) 40 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-01 to 2026-10-20. Most frequent: FRESENIUS MEDCL CARE (2). Each record links to a full report and the official source. Last updated 2026-11-03. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). **Search, filter and export FdaApprovalPulse records** [Run instant live search with these filters](/v/fdaapprovalpulse?type=nda&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdaapprovalpulse/records.csv?type=nda) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## 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) Records 40 Most frequent - FRESENIUS MEDCL CARE (2) - AZURITY (2) - GILEAD SCIENCES INC (2) - GLAXOSMITHKLINE LLC (1) - ALCON LABS INC (1) ## How do I get new fdaApprovalPulse: New drug application (NDA) by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdaapprovalpulse?type=nda) [Watch this exact filter](/v/fdaapprovalpulse?type=nda#more-ways) [See alert plans](/v/fdaapprovalpulse#pricing) ## What are the top fdaApprovalPulse: New drug application (NDA) right now? | Record | Product | Approval | Decided | |---|---|---|---| | 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 | | ALCON LABS INC | BRYTLY | New drug application (NDA) | 2026-10-16 | | COSETTE | EVOXAC | New drug application (NDA) | 2026-10-15 | | BRACCO | ISOVUE READI | New drug application (NDA) | 2026-10-09 | | TEVA | WELTRUZA | New drug application (NDA) | 2026-10-08 | | EVER | TRABECTEDIN | New drug application (NDA) | 2026-10-01 | | ABBVIE | JUVMO | New drug application (NDA) | 2026-09-25 | | ADVENTAPHARMA | ZUEINO | New drug application (NDA) | 2026-09-25 | | AZURITY | LAMLIQUE | New drug application (NDA) | 2026-09-25 | | MIRUM | ATEBRIOZ | New drug application (NDA) | 2026-09-25 | | ELEVAR | LYRFIGTU | New drug application (NDA) | 2026-09-23 | | AGL WELDING SUPPLY CO INC DBA AGL GAS TECHNOLOGIES | CARBON DIOXIDE, USP | New drug application (NDA) | 2026-09-22 | | CURIUM | BEXLUTRY | New drug application (NDA) | 2026-09-14 | | TELIX | Included in the full CSV with every column 🔒 Unlock all 40 records → | | ASTRAZENECA | Included in the full CSV with every column 🔒 Unlock all 40 records → | | IONIS PHARMS INC | Included in the full CSV with every column 🔒 Unlock all 40 records → | Browse 25 more matching record reports - [TELIX](/report/fdaapprovalpulse/telix--dfda-nda218592) - [ASTRAZENECA](/report/fdaapprovalpulse/astrazeneca--dfda-nda220359) - [IONIS PHARMS INC](/report/fdaapprovalpulse/ionis-pharms-inc--dfda-nda220210) - [GILEAD SCIENCES INC](/report/fdaapprovalpulse/gilead-sciences-inc--dfda-nda221104) - [GILEAD SCIENCES INC](/report/fdaapprovalpulse/gilead-sciences-inc--dfda-nda221443) - [BAXTER HLTHCARE CORP](/report/fdaapprovalpulse/baxter-hlthcare-corp--dfda-nda218524) - [CMP DEV LLC](/report/fdaapprovalpulse/cmp-dev-llc--dfda-nda221094) - [OTSUKA PHARMACEUTICAL CO LTD](/report/fdaapprovalpulse/otsuka-pharmaceutical-co-ltd--dfda-nda218145) - [NUVALENT](/report/fdaapprovalpulse/nuvalent--dfda-nda220185) - [NOBLE GAS SOLUTIONS INC.](/report/fdaapprovalpulse/noble-gas-solutions-inc--dfda-nda221805) - [MSD](/report/fdaapprovalpulse/msd--dfda-nda220848) - [CELCUITY](/report/fdaapprovalpulse/celcuity--dfda-nda219908) - [AMNEAL](/report/fdaapprovalpulse/amneal--dfda-nda220790) - [AVYXA HOLDINGS](/report/fdaapprovalpulse/avyxa-holdings--dfda-nda220436) - [GLAXOSMITHKLINE](/report/fdaapprovalpulse/glaxosmithkline--dfda-nda215960) - [AZURITY](/report/fdaapprovalpulse/azurity--dfda-nda218754) - [BAYER HEALTHCARE](/report/fdaapprovalpulse/bayer-healthcare--dfda-nda219627) - [CASPER PHARMA LLC](/report/fdaapprovalpulse/casper-pharma-llc--dfda-nda212927) - [CYCLE](/report/fdaapprovalpulse/cycle--dfda-nda217379) - [SHIONOGI](/report/fdaapprovalpulse/shionogi--dfda-nda220442) - [HAISCO](/report/fdaapprovalpulse/haisco--dfda-nda220482) - [GALDERMA LABS LP](/report/fdaapprovalpulse/galderma-labs-lp--dfda-nda220736) - [CHIESI](/report/fdaapprovalpulse/chiesi--dfda-nda219622) - [APOTEX](/report/fdaapprovalpulse/apotex--dfda-nda220837) - [INCYTE CORP](/report/fdaapprovalpulse/incyte-corp--dfda-nda217180) [Browse all FdaApprovalPulse record reports](/hub/fdaapprovalpulse/records) ## Which related categories and locations should I check? ### 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) [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) ## Frequently asked questions ### How many fdaApprovalPulse: New drug application (NDA) are listed? 40 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), last refreshed automatically. The most recent is dated 2026-10-20. ### Can I get alerts for New drug application (NDA)? Yes. FdaApprovalPulse can email you new records matching this filter; plans are listed on the FdaApprovalPulse page. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). Informational only. [RSS feed of new records](/feed/fdaapprovalpulse.xml) ## Often used together - [FDAPulse](/v/fdapulse) - [FdaNdcDirectoryPulse](/v/fdandcdirectorypulse) - [NycPropertyExemptionDetailPulse](/v/nycpropertyexemptiondetailpulse) - [MigrationRedirectAudit](/migrationredirectaudit) - [SchemaMarkupGeneratorKit](/schemageneratorkit) - [ShopifyStorefrontXray](/shopifystorefrontxray)