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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
    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
  2. 02
    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
  3. 03
    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
  4. 04
    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:
  5. 05
    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:
  6. 06
    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:
  7. 07
    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)
  8. 08
    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
  9. 09
    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
  10. 10
    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:
  11. 11
    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:
  12. 12
    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:
  13. 13
    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:
  14. 14
    FDAMRUS
    FDA Approval for BIZENGRI issued to MERUS N.V.
    Submission status for MERUS N.V.'s drug BIZENGRI (SUPPL-10) with active ingredient ZENOCUTUZUMAB-ZBCO has changed to 'Approval' on 05/08/2026. Application Category: BLA, Application Number: 761352, Application Classification:
  15. 15
    FDAMRUS
    FDA Approval for BIZENGRI issued to MERUS N.V.
    Submission status for MERUS N.V.'s drug BIZENGRI (SUPPL-10) with active ingredient ZENOCUTUZUMAB-ZBCO has changed to 'Approval' on 05/11/2026. Application Category: BLA, Application Number: 761352, Application Classification:
  16. 16
    FDAACAD
    FDA Approval for NUPLAZID issued to ACADIA PHARMS INC
    Submission status for ACADIA PHARMS INC's drug NUPLAZID (SUPPL-16) with active ingredient PIMAVANSERIN TARTRATE has changed to 'Approval' on 05/04/2026. Application Category: NDA, Application Number: 210793, Application Classification: Labeling
  17. 17
    FDAAMGN
    FDA Approval for PAVBLU issued to AMGEN INC
    Submission status for AMGEN INC's drug PAVBLU (SUPPL-5) with active ingredient AFLIBERCEPT-AYYH has changed to 'Approval' on 04/28/2026. Application Category: BLA, Application Number: 761298, Application Classification:
  18. 18
    FDAACAD
    FDA Approval for NUPLAZID issued to ACADIA PHARMS INC
    Submission status for ACADIA PHARMS INC's drug NUPLAZID (SUPPL-16) with active ingredient PIMAVANSERIN TARTRATE has changed to 'Approval' on 04/27/2026. Application Category: NDA, Application Number: 207318, Application Classification: Efficacy
  19. 19
    FDAACAD
    FDA Approval for NUPLAZID issued to ACADIA PHARMS INC
    Submission status for ACADIA PHARMS INC's drug NUPLAZID (SUPPL-14) with active ingredient PIMAVANSERIN TARTRATE has changed to 'Approval' on 04/27/2026. Application Category: NDA, Application Number: 210793, Application Classification: Efficacy
  20. 20
    FDABIIB
    FDA Approval for ZURZUVAE issued to BIOGEN INC
    Submission status for BIOGEN INC's drug ZURZUVAE (SUPPL-3) with active ingredient ZURANOLONE has changed to 'Approval' on 04/20/2026. Application Category: NDA, Application Number: 217369, Application Classification: Labeling
  21. 21
    FDAPRVB
    FDA Approval for TZIELD issued to PROVENTION BIO INC
    Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-13) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 04/20/2026. Application Category: BLA, Application Number: 761183, Application Classification:
  22. 22
    FDASNY
    March 28, 2025 - FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
    For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).“Today’s approval of Qfitlia is significant for patients wi
  23. 23
    FDAAMZN
    March 11, 2025 - FDA Roundup: March 11, 2025
    For Immediate Release: March 11, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA published a General Correspondence Letter issued to Mid-Link Technology Testing Co., Ltd. The FDA is vigilant in ensuring data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device. The FDA has noted an incr
  24. 24
    FDATNDM
    February 28, 2025 - FDA Roundup: February 28, 2025
    For Immediate Release: February 28, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA approved Odactra to include use in individuals 5 through 11 years of age to treat house dust mite induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis). Odactra is an allergen extract immunotherapy
  25. 25
    FDAMIRM
    February 21, 2025 - FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
    For Immediate Release: February 21, 2025 Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.“The FDA is dedicated to supporting new drug development for rare diseases including very rare metabolic diseases like cerebrotendinous xanthomato
  26. 26
    FDASNY
    February 14, 2025 - FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
    For Immediate Release: February 14, 2025 Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Meri
  27. 27
    FDAVRTX
    January 30, 2025 - FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
    For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.  Journavx is the first dr
  28. 28
    FDANBIX
    December 13, 2024 - FDA Approves New Treatment for Congenital Adrenal Hyperplasia
    For Immediate Release: December 13, 2024 Today, the U.S. Food and Drug Administration approved Crenessity (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).“Today’s approval provides an important advance for patients with classic con
  29. 29
    FDAMRUS
    December 6, 2024 - FDA Roundup: December 6, 2024
    For Immediate Release: December 06, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA published the draft guidance, “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics,” which proposes updates to certain agency policies and procedures regarding accelerated approval. Topics addressed by this
  30. 30
    FDAGILD
    FDA Approval for SUNLENCA issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-6) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/25/2024. Application Category: NDA, Application Number: 215973, Application Classification: Efficacy
  31. 31
    FDAGILD
    FDA Approval for SUNLENCA issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-8) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/25/2024. Application Category: NDA, Application Number: 215974, Application Classification: Efficacy
  32. 32
    FDABBIO
    FDA Approval for ATTRUBY issued to BRIDGEBIO PHARMA INC
    Submission status for BRIDGEBIO PHARMA INC's drug ATTRUBY (ORIG-1) with active ingredient ACORAMIDIS has changed to 'Approval' on 11/22/2024. Application Category: NDA, Application Number: 216540, Application Classification: Type 1 - New Molecular Entity
  33. 33
    FDAIMMU
    FDA Approval for TRODELVY issued to IMMUNOMEDICS INC
    Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-58) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 11/22/2024. Application Category: BLA, Application Number: 761115, Application Classification:
  34. 34
    FDAHRTX
    FDA Approval for ZYNRELEF KIT issued to HERON THERAPS INC
    Submission status for HERON THERAPS INC's drug ZYNRELEF KIT (SUPPL-18) with active ingredient BUPIVACAINE; MELOXICAM has changed to 'Approval' on 11/21/2024. Application Category: NDA, Application Number: 211988, Application Classification: Labeling
  35. 35
    FDAAMGN
    FDA Approval for REPATHA issued to AMGEN INC
    Submission status for AMGEN INC's drug REPATHA (SUPPL-44) with active ingredient EVOLOCUMAB has changed to 'Approval' on 11/20/2024. Application Category: BLA, Application Number: 125522, Application Classification:
  36. 36
    FDASNDX
    FDA Approval for REVUFORJ issued to SYNDAX PHARMACEUTICALS INC
    Submission status for SYNDAX PHARMACEUTICALS INC's drug REVUFORJ (ORIG-1) with active ingredient REVUMENIB has changed to 'Approval' on 11/15/2024. Application Category: NDA, Application Number: 218944, Application Classification: Type 1 - New Molecular Entity
  37. 37
    FDAGILD
    FDA Approval for SUNLENCA issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-9) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/13/2024. Application Category: NDA, Application Number: 215973, Application Classification: Manufacturing (CMC)
  38. 38
    FDAGILD
    FDA Approval for SUNLENCA issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-9) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/13/2024. Application Category: NDA, Application Number: 215974, Application Classification: Labeling
  39. 39
    FDACLPT · PTCT
    November 14, 2024 - FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency
    For Immediate Release: November 14, 2024 The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency. “Clinical advancements in the f
  40. 40
    FDASNY
    FDA Approval for SOLIQUA 100/33 issued to SANOFI-AVENTIS US
    Submission status for SANOFI-AVENTIS US's drug SOLIQUA 100/33 (SUPPL-14) with active ingredient INSULIN GLARGINE; LIXISENATIDE has changed to 'Approval' on 11/01/2024. Application Category: BLA, Application Number: 208673, Application Classification:
  41. 41
    FDASNY
    FDA Approval for ADLYXIN issued to SANOFI-AVENTIS US
    Submission status for SANOFI-AVENTIS US's drug ADLYXIN (SUPPL-9) with active ingredient LIXISENATIDE has changed to 'Approval' on 11/01/2024. Application Category: BLA, Application Number: 208471, Application Classification:
  42. 42
    FDANVS
    November 1, 2024 - FDA Roundup: November 1, 2024
    For Immediate Release: November 01, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) and Peter Marks, M.D., Ph.D., director
  43. 43
    FDATGTX
    FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC
    Submission status for TG THERAPEUTICS, INC's drug BRIUMVI (SUPPL-11) with active ingredient UBLITUXIMAB-XIIY has changed to 'Approval' on 10/30/2024. Application Category: BLA, Application Number: 761238, Application Classification:
  44. 44
    FDAHOLX
    October 29, 2024 - FDA Roundup: October 29, 2024
    For Immediate Release: October 29, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA responded to objections on the agency’s final rule that removed the authorized food contact uses of most phthalates because industry abandoned these uses. The FDA evaluated the objections and concluded that they did not provide a basis for mod
  45. 45
    FDASNY
    FDA Approval for SARCLISA issued to SANOFI AVENTIS US
    Submission status for SANOFI AVENTIS US's drug SARCLISA (SUPPL-12) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 10/25/2024. Application Category: BLA, Application Number: 761113, Application Classification:
  46. 46
    FDASNY
    FDA Approval for SARCLISA issued to SANOFI AVENTIS US
    Submission status for SANOFI AVENTIS US's drug SARCLISA (SUPPL-11) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 10/25/2024. Application Category: BLA, Application Number: 761113, Application Classification:
  47. 47
    FDAPFE
    October 25, 2024 - FDA Roundup: October 25, 2024
    For Immediate Release: October 25, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to deter
  48. 48
    FDAGILD
    FDA Approval for BIKTARVY issued to GILEAD SCIENCES INC
    Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-20) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 10/08/2024. Application Category: NDA, Application Number: 210251, Application Classification: Manufacturing (CMC)
  49. 49
    FDAALVO
    FDA Approval for SELARSDI issued to ALVOTECH USA INC
    Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-2) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification:
  50. 50
    FDAALVO
    FDA Approval for SELARSDI issued to ALVOTECH USA INC
    Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-1) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification: