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Week of Oct 20, 2025

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Oct 21, 2025approval299d agoSPEVIGO (SPESOLIMAB-SBZO) — FDA approvalspesolimab

Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →spesolimab →fda approvals ↗

Oct 21, 2025approval299d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 21, 2025approval299d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

Oct 21, 2025approval299d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

Oct 21, 2025approval299d agoCELECOXIB — FDA approvalCelebrex

Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗

Oct 21, 2025approval299d agoTRIAMTERENE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalChartwell Pharmaceuticals LLC

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 21, 2025approval299d agoTRIAMTERENE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalChartwell Pharmaceuticals LLC

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 21, 2025approval299d agoCALCIUM CHLORIDE 10% (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Oct 21, 2025approval299d agoMIEBO (PERFLUOROHEXYLOCTANE) — FDA approvalBausch & Lomb Corp

Sponsor: BAUSCH AND LOMB INC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Oct 21, 2025approval299d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 21, 2025approval299d agoSUMATRIPTAN SUCCINATE — FDA approvalTonix Pharmaceuticals Holding Corp.

Sponsor: PH HEALTH. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →fda approvals ↗

Oct 21, 2025approval299d agoSTIMUFEND (PEGFILGRASTIM-FPGK) — FDA approvalSTIMUFEND

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INJECTION

full page →STIMUFEND →fda approvals ↗

Oct 21, 2025approval299d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →DEFERASIROX →fda approvals ↗

Oct 21, 2025approval299d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →DEFERASIROX →fda approvals ↗

Oct 21, 2025approval299d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →DEFERASIROX →fda approvals ↗

Oct 21, 2025approval299d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →DEFERASIROX →fda approvals ↗

Oct 21, 2025approval299d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →DEFERASIROX →fda approvals ↗

Oct 21, 2025approval299d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →DEFERASIROX →fda approvals ↗

Oct 21, 2025device 510k299d agoOlympus Medical Systems Corporation — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) (510k cleared)

Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoMIPM Mammendorfer Institut für Physik und Medizin GmbH — Neuromuscular Transmission Monitor TOF3D (2510091) (510k cleared)

Product code: KOI. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoAstura Medical — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoSimplivia Healthcare , Ltd. — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (510k cleared)

Product code: ONB. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoMedivis, Inc. — NeuroAlign software (510k cleared)

Product code: HAW. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoMedos International SARL — TriALTIS Spine System (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoEdwards Lifesciences — HemoSphere Stream Module (510k cleared)Edwards Lifesciences Corp

Product code: DQK. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoBodycad Laboratories, Inc. — Fine TTO (510k cleared)Barr Laboratories Inc

Product code: PBF. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoAevumed, Inc. — Aevumed FASE Suture Anchor (510k cleared)

Product code: MBI. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoCardiocycle Medical(Suzhou) Co., Ltd. — Introducer Sheath Set (510k cleared)

Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Oct 21, 2025device 510k299d agoLivsmed, Inc. — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Oct 21, 2025device pma299d agoCordis US Corporation — PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Oct 21, 2025device pma299d agoMedtronic Neuromodulation — Altaviva Implantable Neurostimulator (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Oct 21, 2025device pma299d agoBiotronik, Inc. — Astron Peripheral Self- Expanding Nitinol Stent System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Oct 21, 2025device pma299d agoBiotronik, Inc. — Pulsar-18 T3 Stent System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: NIP. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Oct 21, 2025device pma299d agoInspire Medical Systems — Inspire Upper Airway Stimulation (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

full page →fda device pma ↗

Oct 21, 2025device recall299d agoAccriva Diagnostics, Inc. device recall (Cls III)Co-Diagnostics, Inc.

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. — Reason: Due to an device without a premarket clearance being incorrectly package and distributed. — Status: Ongoing

full page →fda device recalls ↗

Oct 21, 2025device recall299d agoMedtronic MiniMed, Inc. device recall (Cls II)Medtronic USA Inc

CareLink Clinic, REF: MMT-7350 — Reason: Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia. — Status: Ongoing

full page →fda device recalls ↗

Oct 22, 2025approval298d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 22, 2025approval298d agoNICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CAPLIN. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 22, 2025approval298d agoESMOLOL HYDROCHLORIDE — FDA approvalESMOLOL HYDROCHLORIDE

Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

full page →ESMOLOL HYDROCHLORIDE →fda approvals ↗

Oct 22, 2025approval298d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 22, 2025approval298d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 22, 2025approval298d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 22, 2025approval298d agoOXALIPLATIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 22, 2025approval298d agoCONTEPO (FOSFOMYCIN DISODIUM) — FDA approvalfosfomycin disodium

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →fosfomycin disodium →fda approvals ↗

Oct 22, 2025approval298d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 22, 2025approval298d agoVISINE (NAPHAZOLINE HYDROCHLORIDE) — FDA approval

Sponsor: KENVUE BRANDS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Oct 22, 2025approval298d agoLOFEXIDINE HYDROCHLORIDE — FDA approvalLOFEXIDINE HYDROCHLORIDE

Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL

full page →LOFEXIDINE HYDROCHLORIDE →fda approvals ↗

Oct 22, 2025approval298d agoARIPIPRAZOLE — FDA approvalaripiprazole LA

Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL

full page →aripiprazole LA →fda approvals ↗

Oct 22, 2025recall298d agoAscend Laboratories, LLC recall (Cls II)Ascend Laboratories Ltd

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 — Reason: Failed Dissolution Specifications — Status: Ongoing

full page →fda recalls ↗

Oct 22, 2025recall298d agoRising Pharma Holding, Inc. recall (Cls II)CHINA PHARMA HOLDINGS, INC.

Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01 — Reason: Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg). — Status: Ongoing

full page →fda recalls ↗

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