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Latest FDA approvals & regulatory announcements

Live FDA approvals, advisory-committee results, and regulatory press releases. Track biotech catalysts the moment the agency announces them.

  1. 01
    FDAREGN
    FDA Approval for PASATRU issued to REGENERON PHARMACEUTICALS, INC
    Submission status for REGENERON PHARMACEUTICALS, INC's drug PASATRU (ORIG-1) with active ingredient GARETOSMAB has changed to 'Approval' on 08/19/2026. Application Category: BLA, Application Number: 761508, Application Classification:
  2. 02
    FDALCI
    FDA Approval for METAXALONE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug METAXALONE (SUPPL-17) with active ingredient METAXALONE has changed to 'Approval' on 08/19/2026. Application Category: ANDA, Application Number: 204770, Application Classification: Labeling
  3. 03
    FDALCI
    FDA Approval for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUPPL-31) with active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE has changed to 'Approval' on 08/14/2026. Application Category: ANDA, Application Number: 205022, Application Classification: REMS
  4. 04
    FDADCTH
    FDA Approval for HEPZATO issued to DELCATH SYSTEMS INC
    Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-18) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 08/12/2026. Application Category: NDA, Application Number: 201848, Application Classification: REMS
  5. 05
    FDALXRX
    FDA Approval for INPEFA issued to LEXICON PHARMS INC
    Submission status for LEXICON PHARMS INC's drug INPEFA (SUPPL-3) with active ingredient SOTAGLIFLOZIN has changed to 'Approval' on 08/06/2026. Application Category: NDA, Application Number: 216203, Application Classification: Labeling
  6. 06
    FDAGILD
    FDA Approval for VEKLURY issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug VEKLURY (SUPPL-33) with active ingredient REMDESIVIR has changed to 'Approval' on 07/29/2026. Application Category: NDA, Application Number: 214787, Application Classification: Labeling
  7. 07
    FDAVNDA
    FDA Approval for HETLIOZ issued to VANDA PHARMS INC
    Submission status for VANDA PHARMS INC's drug HETLIOZ (SUPPL-13) with active ingredient TASIMELTEON has changed to 'Approval' on 07/27/2026. Application Category: NDA, Application Number: 205677, Application Classification: Manufacturing (CMC)
  8. 08
    FDAOTLK
    FDA Approval for LYTENAVA issued to OUTLOOK THERAPEUTICS, INC.
    Submission status for OUTLOOK THERAPEUTICS, INC.'s drug LYTENAVA (ORIG-1) with active ingredient BEVACIZUMAB-VIKG has changed to 'Approval' on 07/24/2026. Application Category: BLA, Application Number: 761320, Application Classification:
  9. 09
    FDASNY
    FDA Approval for AVAPRO issued to SANOFI AVENTIS US
    Submission status for SANOFI AVENTIS US's drug AVAPRO (SUPPL-81) with active ingredient IRBESARTAN has changed to 'Approval' on 07/24/2026. Application Category: NDA, Application Number: 020757, Application Classification: Labeling
  10. 10
    FDANUVL
    FDA Approval for JIDEYTRO issued to NUVALENT INC
    Submission status for NUVALENT INC's drug JIDEYTRO (ORIG-1) with active ingredient ZIDESAMTINIB has changed to 'Approval' on 07/22/2026. Application Category: NDA, Application Number: 220185, Application Classification: Type 1 - New Molecular Entity
  11. 11
    FDALCI
    FDA Approval for METHADONE HYDROCHLORIDE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-1) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling
  12. 12
    FDALCI
    FDA Approval for METHADONE HYDROCHLORIDE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-7) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling
  13. 13
    FDALCI
    FDA Approval for METHADONE HYDROCHLORIDE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-2) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling
  14. 14
    FDALCI
    FDA Approval for METHADONE HYDROCHLORIDE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-6) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling
  15. 15
    FDACELC
    FDA Approval for REVTORPYK issued to CELCUITY INC..
    Submission status for CELCUITY INC..'s drug REVTORPYK (ORIG-1) with active ingredient GEDATOLISIB has changed to 'Approval' on 07/14/2026. Application Category: NDA, Application Number: 219908, Application Classification: Type 1 - New Molecular Entity
  16. 16
    FDAAMGN
    FDA Approval for REPATHA issued to AMGEN INC
    Submission status for AMGEN INC's drug REPATHA (SUPPL-49) with active ingredient EVOLOCUMAB has changed to 'Approval' on 07/15/2026. Application Category: BLA, Application Number: 125522, Application Classification:
  17. 17
    FDASNY
    FDA Approval for SARCLISA ESCENA issued to SANOFI-AVENTIS U.S. LLC
    Submission status for SANOFI-AVENTIS U.S. LLC's drug SARCLISA ESCENA (ORIG-1) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 07/09/2026. Application Category: BLA, Application Number: 761445, Application Classification:
  18. 18
    FDAVERA
    FDA Approval for TRUTAKNA issued to VERA THERAPEUTICS INC.
    Submission status for VERA THERAPEUTICS INC.'s drug TRUTAKNA (ORIG-1) with active ingredient ATACIEPT-VYMJ has changed to 'Approval' on 07/07/2026. Application Category: BLA, Application Number: 761486, Application Classification:
  19. 19
    FDAVRDN
    FDA Approval for LUMVOA issued to VIRIDIAN THERAPEUTICS INC
    Submission status for VIRIDIAN THERAPEUTICS INC's drug LUMVOA (ORIG-1) with active ingredient VELIGROTUG-VVZE has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761530, Application Classification:
  20. 20
    FDAINSM
    FDA Approval for ARIKAYCE KIT issued to INSMED INC
    Submission status for INSMED INC's drug ARIKAYCE KIT (SUPPL-25) with active ingredient AMIKACIN SULFATE has changed to 'Approval' on 06/25/2026. Application Category: NDA, Application Number: 207356, Application Classification: Labeling
  21. 21
    FDAABBV
    FDA Approval for SKYRIZI issued to ABBVIE INC
    Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-16) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761262, Application Classification:
  22. 22
    FDASNY
    FDA Approval for SARCLISA issued to SANOFI AVENTIS US
    Submission status for SANOFI AVENTIS US's drug SARCLISA (SUPPL-18) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761113, Application Classification:
  23. 23
    FDAABBV
    FDA Approval for SKYRIZI issued to ABBVIE INC
    Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-45) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761105, Application Classification:
  24. 24
    FDAIMMU
    FDA Approval for TRODELVY issued to IMMUNOMEDICS INC
    Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-63) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 06/24/2026. Application Category: BLA, Application Number: 761115, Application Classification:
  25. 25
    FDAIONS
    FDA Approval for TRYNGOLZA (AUTOINJECTOR) issued to IONIS PHARMS INC
    Submission status for IONIS PHARMS INC's drug TRYNGOLZA (AUTOINJECTOR) (SUPPL-4) with active ingredient OLEZARSEN SODIUM has changed to 'Approval' on 06/24/2026. Application Category: NDA, Application Number: 218614, Application Classification: Efficacy
  26. 26
    FDAIMMU
    FDA Approval for TRODELVY issued to IMMUNOMEDICS INC
    Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-64) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 06/24/2026. Application Category: BLA, Application Number: 761115, Application Classification:
  27. 27
    FDALCI
    FDA Approval for HYDROCODONE BITARTRATE AND ACETAMINOPHEN issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL-14) with active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207172, Application Classification: REMS
  28. 28
    FDALCI
    FDA Approval for OXYCODONE AND ACETAMINOPHEN issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug OXYCODONE AND ACETAMINOPHEN (SUPPL-18) with active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207333, Application Classification: REMS
  29. 29
    FDALCI
    FDA Approval for HYDROCODONE BITARTRATE AND ACETAMINOPHEN issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL-14) with active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207171, Application Classification: REMS
  30. 30
    FDALCI
    FDA Approval for OXYCODONE HYDROCHLORIDE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug OXYCODONE HYDROCHLORIDE (SUPPL-16) with active ingredient OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 203823, Application Classification: REMS
  31. 31
    FDALCI
    FDA Approval for CODEINE SULFATE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug CODEINE SULFATE (SUPPL-21) with active ingredient CODEINE SULFATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 203046, Application Classification: REMS
  32. 32
    FDAAMPH
    FDA Approval for REXTOVY issued to AMPHASTAR PHARMS INC
    Submission status for AMPHASTAR PHARMS INC's drug REXTOVY (SUPPL-2) with active ingredient NALOXONE HYDROCHLORIDE has changed to 'Approval' on 06/16/2026. Application Category: NDA, Application Number: 208969, Application Classification: Efficacy
  33. 33
    FDAABBV
    FDA Approval for SKYRIZI issued to ABBVIE INC
    Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-44) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761105, Application Classification:
  34. 34
    FDAABBV
    FDA Approval for SKYRIZI issued to ABBVIE INC
    Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-15) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761262, Application Classification:
  35. 35
    FDAPRVB
    FDA Approval for TZIELD issued to PROVENTION BIO INC
    Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-10) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761183, Application Classification:
  36. 36
    FDAPRVB
    FDA Approval for TZIELD issued to PROVENTION BIO INC
    Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-14) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761183, Application Classification:
  37. 37
    FDAPFE
    FDA Approval for HYMPAVZI issued to PFIZER INC
    Submission status for PFIZER INC's drug HYMPAVZI (SUPPL-3) with active ingredient MARSTACIMAB-HNCQ has changed to 'Approval' on 06/05/2026. Application Category: BLA, Application Number: 761369, Application Classification:
  38. 38
    FDASNY
    FDA Approval for CHILDREN'S ALLEGRA ALLERGY issued to CHATTEM SANOFI
    Submission status for CHATTEM SANOFI's drug CHILDREN'S ALLEGRA ALLERGY (SUPPL-19) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 06/04/2026. Application Category: NDA, Application Number: 021909, Application Classification: Labeling
  39. 39
    FDASNY
    FDA Approval for CHILDREN'S ALLEGRA HIVES issued to CHATTEM SANOFI
    Submission status for CHATTEM SANOFI's drug CHILDREN'S ALLEGRA HIVES (SUPPL-19) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 06/04/2026. Application Category: NDA, Application Number: 021909, Application Classification: Labeling
  40. 40
    FDADCTH
    FDA Approval for HEPZATO issued to DELCATH SYSTEMS INC
    Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-16) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 05/29/2026. Application Category: NDA, Application Number: 201848, Application Classification: REMS
  41. 41
    FDAABBV
    FDA Approval for DECNUPAZ issued to ABBVIE INC
    Submission status for ABBVIE INC's drug DECNUPAZ (ORIG-1) with active ingredient PIVEKIMAB SUNIRINE-PVZY has changed to 'Approval' on 05/27/2026. Application Category: BLA, Application Number: 761460, Application Classification:
  42. 42
    FDAGILD
    FDA Approval for HEPCLUDEX issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug HEPCLUDEX (ORIG-1) with active ingredient BULEVIRTIDE-GMOD) has changed to 'Approval' on 05/22/2026. Application Category: BLA, Application Number: 761468, Application Classification:
  43. 43
    FDARDY
    FDA Tentative Approval for PALBOCICLIB issued to DR. REDDY'S LABORATORIES LIMITED
    Submission status for DR. REDDY'S LABORATORIES LIMITED's drug PALBOCICLIB (ORIG-1) with active ingredient PALBOCICLIB has changed to 'Tentative Approval' on 05/15/2026. Application Category: ANDA, Application Number: 220444, Application Classification:
  44. 44
    FDAGILD
    FDA Approval for BIKTARVY issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-26) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 05/21/2026. Application Category: NDA, Application Number: 210251, Application Classification: Manufacturing (CMC)
  45. 45
    FDAGILD
    FDA Approval for BIKTARVY issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-26) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 05/21/2026. Application Category: NDA, Application Number: 210251, Application Classification: Labeling
  46. 46
    FDASNY
    FDA Approval for XYZAL ALLERGY 24HR issued to CHATTEM SANOFI
    Submission status for CHATTEM SANOFI's drug XYZAL ALLERGY 24HR (SUPPL-10) with active ingredient LEVOCETIRIZINE DIHYDROCHLORIDE has changed to 'Approval' on 05/20/2026. Application Category: NDA, Application Number: 209089, Application Classification: Labeling
  47. 47
    FDAAMGN
    FDA Approval for WEZLANA issued to AMGEN INC
    Submission status for AMGEN INC's drug WEZLANA (SUPPL-6) with active ingredient USTEKINUMAB-AUUB has changed to 'Approval' on 05/12/2026. Application Category: BLA, Application Number: 761331, Application Classification:
  48. 48
    FDAAMGN
    FDA Approval for WEZLANA issued to AMGEN INC
    Submission status for AMGEN INC's drug WEZLANA (SUPPL-6) with active ingredient USTEKINUMAB-AUUB has changed to 'Approval' on 05/12/2026. Application Category: BLA, Application Number: 761285, Application Classification:
  49. 49
    FDAAMGN
    FDA Approval for WEZLANA issued to AMGEN INC
    Submission status for AMGEN INC's drug WEZLANA (SUPPL-6) with active ingredient USTEKINUMAB-AUUB has changed to 'Approval' on 05/13/2026. Application Category: BLA, Application Number: 761331, Application Classification:
  50. 50
    FDAAMGN
    FDA Approval for WEZLANA issued to AMGEN INC
    Submission status for AMGEN INC's drug WEZLANA (SUPPL-6) with active ingredient USTEKINUMAB-AUUB has changed to 'Approval' on 05/13/2026. Application Category: BLA, Application Number: 761285, Application Classification: