Calendar

pharmadog

Week of Sep 29, 2025

Oct 2, 2025approval315d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →teclistamab →fda approvals ↗

Oct 2, 2025approval315d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →talquetamab →fda approvals ↗

Oct 2, 2025approval315d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

full page →lurbinectedin →fda approvals ↗

Oct 2, 2025approval315d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 2, 2025approval315d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗

Oct 2, 2025approval315d agoTECENTRIQ HYBREZA (ATEZOLIZUMAB AND HYALURONIDASE-TQJS) — FDA approval(atezolizumab + hyaluronidase (human recombinant))

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

full page →(atezolizumab + hyaluronidase (human recombinant)) →fda approvals ↗

Oct 2, 2025approval315d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

full page →atezolizumab →fda approvals ↗

Oct 2, 2025approval315d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLIN ER →fda approvals ↗

Oct 2, 2025approval315d agoCROMOLYN SODIUM — FDA approvalVitalgenics LLC

Sponsor: TEVA PHARMS. Form: SOLUTION. Route: INHALATION

full page →fda approvals ↗

Oct 2, 2025approval315d agoMETADATE ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE ER

Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METADATE ER →fda approvals ↗

Oct 2, 2025approval315d agoMETADATE ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE ER

Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METADATE ER →fda approvals ↗

Oct 2, 2025approval315d agoEYDENZELT (AFLIBERCEPT-BOAV) — FDA approvalEYDENZELT

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION

full page →EYDENZELT →fda approvals ↗

Oct 2, 2025approval315d agoSEVOFLURANE — FDA approvalSEVOFLURANE

Sponsor: BAXTER HLTHCARE. Form: LIQUID. Route: INHALATION

full page →SEVOFLURANE →fda approvals ↗

Oct 2, 2025approval315d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval315d agoVANCOMYCIN HYDROCHLORIDE — FDA approvalSamson Medical Technologies LLC

Sponsor: STERISCIENCE. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 2, 2025approval315d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 2, 2025approval315d agoPILOCARPINE HYDROCHLORIDE — FDA approvalPILOCARPINE HYDROCHLORIDE

Sponsor: FDC LTD. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →PILOCARPINE HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval315d agoOSELTAMIVIR PHOSPHATE — FDA approvalF. Hoffmann-La Roche Ltd

Sponsor: ZHEJIANG POLY PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 2, 2025approval315d agoMIRTAZAPINE — FDA approvalmirtazapine ODT

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

full page →mirtazapine ODT →fda approvals ↗

Oct 2, 2025approval315d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHARTWELL MOLECULAR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Oct 2, 2025approval315d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHARTWELL MOLECULAR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Oct 2, 2025approval315d agoETRAVIRINE — FDA approvalETRAVIRINE

Sponsor: BIONPHARMA. Form: TABLET. Route: ORAL

full page →ETRAVIRINE →fda approvals ↗

Oct 2, 2025device 510k315d agoShenzhen Enmind Technology Co., Ltd. — IPL Hair Removal Device (IPL-001, IPL-002) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoNingbo Tianyi Medical Appliance Co., Ltd. — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoGC America, Inc. — G-Bond Universal (510k cleared)PARKS AMERICA, INC

Product code: KLE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSpace Cardiovascular (510k cleared)

Product code: LLZ. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoShenzhen Finicare Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoSimergent, LLC — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoThirona BV — LungQ 4 (510k cleared)

Product code: JAK. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoLiofilchem s.r.l. — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (510k cleared)Bristol-Myers Squibb Co

Product code: JWY. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoArtivion, Inc. — CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (510k cleared)ARTIVION, INC.

Product code: OHA. Advisory committee: Unknown. Type: Special

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoExemplar Medical, LLC — BreatheBand® (Model 1000) (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoShenzhen Sophway Technology Co., Ltd. — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoIngeniars S.R.L. — EasyTeleMed (2.0.2) (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoApplied Medical Resources Corp. — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (510k cleared)PATH

Product code: HEW. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k315d agoOrthonovis, Inc. — Cannulated Screw and Kirschner (K wire) System (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device pma315d agoEdwards Lifesciences, LLC — PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoW. L. Gore & Associates, Inc. — GORE® TAG® Conformable Thoracic Endoprosthesis (PMA supplement)

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoMedtronic Minimed, Inc. — MiniMed 670G System (PMA supplement)Medtronic USA Inc

Supplement type: Special (Immediate Track). Product code: OZP. Advisory committee: CH. Decision: APPR

full page →fda device pma ↗

Oct 2, 2025device pma315d agoMedtronic, Inc. — Percepta Bipolar CRTP; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P; (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Attesta DR (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

Supplement type: 135 Review Track For 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Oct 2, 2025device pma315d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoBoston Scientific Corp — AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoMedtronic, Inc. — Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoMedtronic Vascular, Inc. — EverFlex Self-expanding Peripheral Stent System (PMA supplement)

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

full page →fda device pma ↗

Oct 2, 2025device pma315d agoValencia Technologies Corporation — eCoin Tibial Nerve Stimulator System (PMA supplement)

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

full page →fda device pma ↗

Oct 2, 2025device recall315d agoCerenovus Inc device recall (Cls I)

CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT 8MM — Reason: Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. — Status: Ongoing

Oct 2, 2025device recall315d agoICU Medical, Inc. device recall (Cls I)ICU MEDICAL INC/DE

IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014 — Reason: IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body. — Status: Ongoing

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Week of Sep 29, 2025