Calendar

pharmadog

Week of Jan 26, 2026

Jan 27, 2026approval197d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 27, 2026approval197d agoMESNA — FDA approvalRiconpharma LLC

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 27, 2026approval197d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: NATCO. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Jan 27, 2026approval197d agoPROPRANOLOL HYDROCHLORIDE — FDA approvalpropranolol hydrochloride ER

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

full page →propranolol hydrochloride ER →fda approvals ↗

Jan 27, 2026approval197d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

full page →TRAVOPROST →fda approvals ↗

Jan 27, 2026approval197d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

full page →TRAVOPROST →fda approvals ↗

Jan 27, 2026approval197d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

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Jan 27, 2026approval197d agoCAPECITABINE — FDA approvalArmas Pharmaceuticals Inc

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

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Jan 27, 2026approval197d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

full page →vandetanib →fda approvals ↗

Jan 27, 2026approval197d agoPRIFTIN (RIFAPENTINE) — FDA approvalrifapentine

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

full page →rifapentine →fda approvals ↗

Jan 27, 2026approval197d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Jan 27, 2026approval197d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: SUN PHARM INDS INC. Form: SUSPENSION. Route: ORAL

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Jan 27, 2026approval197d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Jan 27, 2026device 510k197d agoSoniquence, LLC — Reusable 3 Button Fingerswitch Wand (510k cleared)

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

full page →fda device 510k ↗

Jan 27, 2026device 510k197d agoBalt USA, LLC — Optima Coil System (OptiOne Coil System) (510k cleared)Bayer USA LLC

Product code: HCG. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗

Jan 27, 2026device 510k197d agoInbella Medical, Inc. — InbellaIgnite RF System (510k cleared)

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

full page →fda device 510k ↗

Jan 27, 2026device 510k197d agoBeckman Coulter, Inc. — Access anti-HAV IgM (510k cleared)

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

full page →fda device 510k ↗

Jan 27, 2026device 510k197d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

full page →fda device 510k ↗

Jan 27, 2026device pma197d agoBoston Scientific Corp — WOLVERINE Coronary Cutting Balloon (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Jan 27, 2026device pma197d agoMedtronic Vascular — Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System (PMA supplement)

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

full page →fda device pma ↗

Jan 27, 2026device recall197d agoAbiomed, Inc. device recall (Cls I)Abion Inc

Impella RP Flex with SmartAssist. Product Code: 1000323. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing

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Jan 27, 2026device recall197d agoAbiomed, Inc. device recall (Cls I)Abion Inc

Impella RP with SmartAssist. Product Code: 0046-0035. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing

full page →fda device recalls ↗

Jan 27, 2026device recall197d agoAbiomed, Inc. device recall (Cls I)Abion Inc

Impella RP. Product Code: 0046-0011. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing

full page →fda device recalls ↗

Jan 27, 2026device recall197d agoBecton Dickinson & Company device recall (Cls II)BECTON DICKINSON & CO

10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. — Reason: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. — Status: Ongoing

full page →fda device recalls ↗

Jan 27, 2026device recall197d agoLutronic Corporation device recall (Cls II)

CLARITY II Laser System; Model No. 1110200210. — Reason: Reports of devices sparking/popping and potentially burning patients. — Status: Ongoing

full page →fda device recalls ↗

Jan 27, 2026grant197d agoUNIVERSITY OF MINNESOTA — Testing the role of microbial infections in the development of auto-antibodie...University of Minnesota

AI grant. $43,914. PI: Adrianna M. Rivera-León

full page →nih reporter ↗

Jan 27, 2026grant197d agoUNIVERSITY OF CALIFORNIA LOS ANGELES — Predicting ASD Outcomes Using Quantitative Movement Metrics in InfancyUniversity of California Los Angeles

NS grant. $625,859. PI: Rujuta Bhatt Wilson

full page →nih reporter ↗

Jan 27, 2026grant197d agoALBERT EINSTEIN COLLEGE OF MEDICINE — Understanding how T cell receptor recognition of peptide ligands shapes memor...Albert Einstein College of Medicine

AI grant. $780,787. PI: Gregoire Stephane Lauvau

full page →nih reporter ↗

Jan 28, 2026approval196d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

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Jan 28, 2026approval196d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

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Jan 28, 2026approval196d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

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Jan 28, 2026approval196d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Jan 28, 2026approval196d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Jan 28, 2026approval196d agoYUVEZZI (BRIMONIDINE TARTRATE) — FDA approvalBausch & Lomb Corp

Sponsor: VISUS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Jan 28, 2026approval196d agoDAYSEE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

Jan 28, 2026approval196d agoISOSULFAN BLUE — FDA approvalISOSULFAN BLUE

Sponsor: MYLAN INSTITUTIONAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ISOSULFAN BLUE →fda approvals ↗

Jan 28, 2026approval196d agoCLOMIPRAMINE HYDROCHLORIDE — FDA approvalTruPharma LLC

Sponsor: TARO. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026approval196d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

Jan 28, 2026approval196d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Jan 28, 2026approval196d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

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

full page →fda approvals ↗

Jan 28, 2026approval196d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

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

full page →fda approvals ↗

Jan 28, 2026recall196d agoCipla USA, Inc. recall (Cls III)Cipla USA Inc

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39 — Reason: Failed PH Specifications — Status: Ongoing

full page →fda recalls ↗

Jan 28, 2026recall196d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07 — Reason: Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients. — Status: Ongoing

full page →fda recalls ↗

Jan 28, 2026recall196d agoGraviti Pharmaceuticals Private Limited recall (Cls II)Graviti Pharmaceuticals Inc

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10. — Reason: Presence of Foreign Substance — Status: Ongoing

full page →fda recalls ↗

Jan 28, 2026recall196d agoSpecialty Process Labs LLC recall (Cls II)

Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02 — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Jan 28, 2026device 510k196d agoEver Fortune.Ai, Co., Ltd. — Seg Pro V3 (RT-300) (510k cleared)

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

full page →fda device 510k ↗

Jan 28, 2026device 510k196d agoNingbo Zhenhai Yihao Electronic Technology Co., Ltd. — Hand Massager (SM004D) (510k cleared)

Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Jan 28, 2026device 510k196d agoSterivic Medical Co., Ltd. — Sterilization Pouch/Roll (510k cleared)

Product code: FRG. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Jan 28, 2026device 510k196d agoSleepiz AG — Sleepiz One+ (Model 2.5) (510k cleared)

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

full page →fda device 510k ↗

Jan 28, 2026device 510k196d agoKoru Medical Systems, Inc. — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (510k cleared)KORU Medical Systems, Inc.

Product code: FRN. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

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Week of Jan 26, 2026