Calendar

pharmadog

Week of Feb 2, 2026

Feb 2, 2026approval191d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Feb 2, 2026approval191d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Feb 2, 2026approval191d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Feb 2, 2026approval191d agoMETHYLENE BLUE — FDA approvalMETHYLENE BLUE

Sponsor: ZYDUS LIFESCIENCES. Form: SOLUTION. Route: INTRAVENOUS

full page →METHYLENE BLUE →fda approvals ↗

Feb 2, 2026approval191d agoTYRUKO (NATALIZUMAB-SZTN) — FDA approvalnatalizumab biosimilar

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

full page →natalizumab biosimilar →fda approvals ↗

Feb 2, 2026approval191d agoLENALIDOMIDE — FDA approvalLENALIDOMIDE

Sponsor: CIPLA. Form: CAPSULE. Route: ORAL

full page →LENALIDOMIDE →fda approvals ↗

Feb 2, 2026approval191d agoPRIMAQUINE (PRIMAQUINE PHOSPHATE) — FDA approvalprimaquine phosphate

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →primaquine phosphate →fda approvals ↗

Feb 2, 2026approval191d agoNORLIQVA (AMLODIPINE BESYLATE) — FDA approvalChina Resources Saike Pharmaceutical Co Ltd

Sponsor: CMP DEV LLC. Form: SOLUTION. Route: ORAL

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Feb 2, 2026approval191d agoAIR — FDA approval

Sponsor: GENERAL AIR SERVICE & SUPPLY COMPANY. Form: GAS. Route: INHALATION

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Feb 2, 2026approval191d agoPUR-WASH (PURIFIED WATER) — FDA approval

Sponsor: NIAGARA PHARMS. Form: SOLUTION. Route: OPHTHALMIC

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Feb 2, 2026approval191d agoFIDAXOMICIN — FDA approvalDificid

Sponsor: APOTEX. Form: TABLET. Route: ORAL

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Feb 2, 2026approval191d agoPREGABALIN — FDA approvalPREGABALIN

Sponsor: APOTEX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PREGABALIN →fda approvals ↗

Feb 2, 2026approval191d agoMIRTAZAPINE — FDA approvalmirtazapine ODT

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

full page →mirtazapine ODT →fda approvals ↗

Feb 2, 2026approval191d agoESTRADIOL — FDA approvalLong Grove Pharmaceuticals LLC

Sponsor: LONG GROVE PHARMS. Form: GEL, METERED. Route: TRANSDERMAL

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Feb 2, 2026approval191d agoPREGABALIN — FDA approvalViatris Inc

Sponsor: CHANGZHOU PHARM. Form: CAPSULE. Route: ORAL

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Feb 2, 2026device 510k191d agoNano-X Imaging , Ltd. — TAP2D (510k cleared)Nano-X Imaging Ltd.

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

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Feb 2, 2026device 510k191d agoChengdu Besmile Medical Technology Co., Ltd. — BIORES Dental Implant System (510k cleared)

Product code: DZE. Advisory committee: Dental. Type: Abbreviated

full page →fda device 510k ↗

Feb 2, 2026device 510k191d agoOxehealth Limited — Vital Signs (510k cleared)

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

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Feb 2, 2026device 510k191d agoBeijing Kreate Medical Co., Ltd. — Redermax Antibacterial Wound Matrix (510k cleared)

Product code: FRO. Advisory committee: Unknown. Type: Traditional

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Feb 2, 2026device 510k191d agoAsahi Intecc Co., Ltd. — CHIKAI Nexus petit (510k cleared)

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

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Feb 2, 2026device pma191d agoPhilips Medical Systems, Inc. — HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

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Feb 2, 2026device pma191d agoCooperVision, Inc. — Biofmity XR Torie (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

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Feb 2, 2026device pma191d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

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Feb 2, 2026device pma191d agoPhilips Medical Systems — HeartStart FRx Defibrillator (PMA supplement)

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

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Feb 2, 2026device recall191d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing

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Feb 2, 2026device recall191d agoHowmedica Osteonics Corp. device recall (Cls II)

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 — Reason: A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment. — Status: Ongoing

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Feb 2, 2026device recall191d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing

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Feb 2, 2026device recall191d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing

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Feb 2, 2026grant191d agoUNIVERSITY OF GEORGIA — Establishing a cystic fibrosis ferret model of chronic Mycobacterium abscessu...

AI grant. $224,857. PI: Tuhina Gupta

Week of Feb 2, 2026