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- Biologic license (BLA)

# FdaApprovalPulse: Biologic license (BLA)

**17 fdaApprovalPulse: Biologic license (BLA) are listed from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-07 to 2026-10-22; the most frequent is ACCORD BIOPHARMA INC. with 2. Data last updated 2026-11-04; each record links to its official source and a full report.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdaapprovalpulse) from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) Copy citation

Download all 17 fdaApprovalPulse: Biologic license (BLA) (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=bla)

17 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-07 to 2026-10-22. Most frequent: ACCORD BIOPHARMA INC. (2). Each record links to a full report and the official source.

Last updated 2026-11-04. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

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Records

17

Most frequent

- ACCORD BIOPHARMA INC. (2)
- AMGEN INC (1)
- SANDOZ INC (1)
- TEVA PHARMACEUTICALS, INC. (1)
- ELI LILLY AND CO (1)

## How do I get new fdaApprovalPulse: Biologic license (BLA) by email?

Search, filter and export these records, or get alerts when new ones appear.

[Search and filter](/v/fdaapprovalpulse?type=bla) [Watch this exact filter](/v/fdaapprovalpulse?type=bla#more-ways) [See alert plans](/v/fdaapprovalpulse#pricing)

## What are the top fdaApprovalPulse: Biologic license (BLA) right now?

| Record | Product | Approval | Decided |
|---|---|---|---|
| AMGEN INC | PAVBLU | Biologic license (BLA) | 2026-10-22 |
| SANDOZ INC | ENZEEVU | Biologic license (BLA) | 2026-10-22 |
| TEVA PHARMACEUTICALS, INC. | DEGEVMA | Biologic license (BLA) | 2026-09-25 |
| ELI LILLY AND CO | ONSWIK | Biologic license (BLA) | 2026-09-23 |
| SCHOLAR ROCK INC | ISEMBYLD | Biologic license (BLA) | 2026-09-11 |
| REGENERON PHARMACEUTICALS, INC | PASATRU | Biologic license (BLA) | 2026-08-19 |
| DR REDDYS LABS SA | ZIMRIXBY | Biologic license (BLA) | 2026-07-31 |
| OUTLOOK THERAPEUTICS, INC. | LYTENAVA | Biologic license (BLA) | 2026-07-24 |
| EMERGE BIOSCIENCE PTE. LTD. | GARZULYS | Biologic license (BLA) | 2026-07-24 |
| SANOFI-AVENTIS U.S. LLC | SARCLISA ESCENA | Biologic license (BLA) | 2026-07-09 |
| VERA THERAPEUTICS INC. | TRUTAKNA | Biologic license (BLA) | 2026-07-07 |
| VIRIDIAN THERAPEUTICS INC | LUMVOA | Biologic license (BLA) | 2026-06-26 |
| LUPIN LIMITED | RANLUSPEC | Biologic license (BLA) | 2026-06-02 |
| ABBVIE INC | DECNUPAZ | Biologic license (BLA) | 2026-05-27 |
| GILEAD SCIENCES INC | HEPCLUDEX | Biologic license (BLA) | 2026-05-22 |
| ACCORD BIOPHARMA INC. | Included in the full CSV with every column 🔒 Unlock all 17 records → |
| ACCORD BIOPHARMA INC. | Included in the full CSV with every column 🔒 Unlock all 17 records → |

Browse 2 more matching record reports
- [ACCORD BIOPHARMA INC.](/report/fdaapprovalpulse/accord-biopharma-inc--dfda-bla761452)
- [ACCORD BIOPHARMA INC.](/report/fdaapprovalpulse/accord-biopharma-inc--dfda-bla761147)

[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 (1180)](/hub/fdaapprovalpulse/type/suppl-labeling) [PMA supplement (device change) (367)](/hub/fdaapprovalpulse/type/pma-supplement) [Generic drug approval (ANDA) (196)](/hub/fdaapprovalpulse/type/anda) [Drug efficacy supplement (new indication or use) (77)](/hub/fdaapprovalpulse/type/suppl-efficacy) [Drug manufacturing (CMC) supplement (55)](/hub/fdaapprovalpulse/type/suppl-manufacturing) [New drug application (NDA) (41)](/hub/fdaapprovalpulse/type/nda) [PMA original approval (new class III device) (24)](/hub/fdaapprovalpulse/type/pma-original) [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: Biologic license (BLA) are listed?

17 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), last refreshed automatically. The most recent is dated 2026-10-22.

### Can I get alerts for Biologic license (BLA)?

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)

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- [FDAPulse](/v/fdapulse)
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