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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
    FDAAMGN
    FDA Approval for REPATHA issued to AMGEN INC
    Submission status for AMGEN INC's drug REPATHA (SUPPL-47) with active ingredient EVOLOCUMAB has changed to 'Approval' on 10/09/2026. Application Category: BLA, Application Number: 125522, Application Classification:
  2. 02
    FDALCI
    FDA Approval for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-5) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 10/05/2026. Application Category: ANDA, Application Number: 214403, Application Classification: Labeling
  3. 03
    FDALCI
    FDA Approval for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-6) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 10/05/2026. Application Category: ANDA, Application Number: 214403, Application Classification: Labeling
  4. 04
    FDAABBV
    FDA Approval for JUVMO issued to ABBVIE INC
    Submission status for ABBVIE INC's drug JUVMO (ORIG-1) with active ingredient TAVAPADON has changed to 'Approval' on 09/25/2026. Application Category: NDA, Application Number: 220415, Application Classification: Type 1 - New Molecular Entity
  5. 05
    FDAPFE
    FDA Approval for RUXIENCE issued to PFIZER INC
    Submission status for PFIZER INC's drug RUXIENCE (SUPPL-20) with active ingredient RITUXIMAB-PVVR has changed to 'Approval' on 09/28/2026. Application Category: BLA, Application Number: 761103, Application Classification:
  6. 06
    FDALCI
    FDA Approval for LISDEXAMFETAMINE DIMESYLATE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug LISDEXAMFETAMINE DIMESYLATE (SUPPL-8) with active ingredient LISDEXAMFETAMINE DIMESYLATE has changed to 'Approval' on 09/24/2026. Application Category: ANDA, Application Number: 215802, Application Classification: Labeling
  7. 07
    FDALCI
    FDA Approval for LISDEXAMFETAMINE DIMESYLATE issued to LANNETT CO INC
    Submission status for LANNETT CO INC's drug LISDEXAMFETAMINE DIMESYLATE (SUPPL-6) with active ingredient LISDEXAMFETAMINE DIMESYLATE has changed to 'Approval' on 09/24/2026. Application Category: ANDA, Application Number: 215802, Application Classification: Labeling
  8. 08
    FDAAMGN
    FDA Approval for RIABNI issued to AMGEN INC
    Submission status for AMGEN INC's drug RIABNI (SUPPL-5) with active ingredient RITUXIMAB-ARRX has changed to 'Approval' on 09/29/2026. Application Category: BLA, Application Number: 761140, Application Classification:
  9. 09
    FDAPFE
    FDA Approval for RUXIENCE issued to PFIZER INC
    Submission status for PFIZER INC's drug RUXIENCE (SUPPL-20) with active ingredient RITUXIMAB-PVVR has changed to 'Approval' on 09/29/2026. Application Category: BLA, Application Number: 761103, Application Classification:
  10. 10
    FDAAGIO
    FDA Approval for PYRUKYND issued to AGIOS PHARMS INC
    Submission status for AGIOS PHARMS INC's drug PYRUKYND (SUPPL-7) with active ingredient MITAPIVAT SULFATE has changed to 'Approval' on 09/28/2026. Application Category: NDA, Application Number: 216196, Application Classification: Manufacturing (CMC)
  11. 11
    FDAAGIO
    FDA Approval for AQVESME issued to AGIOS PHARMS INC
    Submission status for AGIOS PHARMS INC's drug AQVESME (SUPPL-7) with active ingredient MITAPIVAT SULFATE has changed to 'Approval' on 09/28/2026. Application Category: NDA, Application Number: 216196, Application Classification: Manufacturing (CMC)
  12. 12
    FDAAMGN
    FDA Approval for IMDELLTRA issued to AMGEN INC
    Submission status for AMGEN INC's drug IMDELLTRA (SUPPL-2) with active ingredient TARLATAMAB-DLLE has changed to 'Approval' on 09/11/2026. Application Category: BLA, Application Number: 761344, Application Classification:
  13. 13
    FDAIONS
    FDA Approval for ZANVASTRO issued to IONIS PHARMS INC
    Submission status for IONIS PHARMS INC's drug ZANVASTRO (ORIG-1) with active ingredient ZILGANERSEN has changed to 'Approval' on 09/03/2026. Application Category: NDA, Application Number: 220210, Application Classification: Type 1 - New Molecular Entity
  14. 14
    FDAGILD
    FDA Approval for SUNLENCA issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-17) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 08/27/2026. Application Category: NDA, Application Number: 215974, Application Classification: Efficacy
  15. 15
    FDAGILD
    FDA Approval for SUNLENCA issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-24) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 08/27/2026. Application Category: NDA, Application Number: 215973, Application Classification: Efficacy
  16. 16
    FDARVMD
    FDA Approval for RASONQUE issued to REVOLUTION MEDICINES INC
    Submission status for REVOLUTION MEDICINES INC's drug RASONQUE (ORIG-1) with active ingredient DARAXONRASIB has changed to 'Approval' on 08/26/2026. Application Category: NDA, Application Number: 220910, Application Classification: Type 1 - New Molecular Entity
  17. 17
    FDARDY
    FDA Tentative Approval for BEMPEDOIC ACID issued to DR. REDDY'S LABORATORIES LIMITED
    Submission status for DR. REDDY'S LABORATORIES LIMITED's drug BEMPEDOIC ACID (ORIG-1) with active ingredient BEMPEDOIC ACID has changed to 'Tentative Approval' on 08/06/2026. Application Category: ANDA, Application Number: 219312, Application Classification:
  18. 18
    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:
  19. 19
    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
  20. 20
    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
  21. 21
    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
  22. 22
    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
  23. 23
    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
  24. 24
    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)
  25. 25
    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:
  26. 26
    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
  27. 27
    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
  28. 28
    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
  29. 29
    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
  30. 30
    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
  31. 31
    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
  32. 32
    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
  33. 33
    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:
  34. 34
    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:
  35. 35
    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:
  36. 36
    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:
  37. 37
    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
  38. 38
    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:
  39. 39
    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:
  40. 40
    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:
  41. 41
    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:
  42. 42
    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
  43. 43
    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:
  44. 44
    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
  45. 45
    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
  46. 46
    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
  47. 47
    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
  48. 48
    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
  49. 49
    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
  50. 50
    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: