Live FDA approvals and announcements.
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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
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
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
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:
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:
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:
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)
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
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
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:
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:
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:
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:
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:
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:
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
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:
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
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
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
