Calendar

pharmadog

Week of Dec 29, 2025

Dec 31, 2025approval231d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 31, 2025approval231d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval231d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval231d agoGLATIRAMER ACETATE — FDA approvalGLATIRAMER ACETATE

Sponsor: SCINOPHARM TAIWAN. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Dec 31, 2025approval231d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DICLOFENAC SODIUM →fda approvals ↗

Dec 31, 2025approval231d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 31, 2025approval231d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 31, 2025approval231d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 31, 2025approval231d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 31, 2025approval231d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARMOBEDIENT. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval231d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval231d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval231d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 31, 2025approval231d agoSELENIOUS ACID — FDA approvalSELENIOUS ACID

Sponsor: RK PHARMA. Form: SOLUTION. Route: INTRAVENOUS

full page →SELENIOUS ACID →fda approvals ↗

Dec 31, 2025approval231d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval231d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: AUROBINDO PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Dec 31, 2025approval231d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval231d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval231d agoATORVASTATIN CALCIUM — FDA approvalViatris Inc

Sponsor: UMEDICA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025recall231d agoMerck Sharp & Dohme LLC recall (Cls II)Merck Sharp & Dohme LLC

Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03 — Reason: Presence of particulate matter: potential presence of metal particulates in the product. — Status: Ongoing

full page →fda recalls ↗

Dec 31, 2025recall231d agoMerck Sharp & Dohme LLC recall (Cls II)Merck Sharp & Dohme LLC

Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02. — Reason: Presence of particulate matter: potential presence of metal particulates in the product. — Status: Ongoing

full page →fda recalls ↗

Dec 31, 2025device 510k231d agoShenzhen Jiantuo Electronics Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device 510k231d agoNeurofield, Inc. — Genesis Sleep (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device 510k231d agoStryker Endoscopy — MOLLI 2 System (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device 510k231d agoTyber Medical, LLC — Tyber Medical Trauma Screw (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device 510k231d agoArc Trauma, LLC — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device pma231d agoRoche Molecular System, Inc. — cobas® EZH2 Mutation Test (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWD. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device pma231d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device pma231d agoRoche Molecular Systems, Inc. — cobas® KRAS Mutation Test (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWD. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device pma231d agoSmith & Nephew, Inc. — Ascension MCP (PMA supplement)SMITH & NEPHEW PLC

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

full page →fda device pma ↗

Dec 31, 2025device pma231d agoNeurolief , Ltd. — ProlivRx System (PMA)

Product code: JXK. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Dec 31, 2025device pma231d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device pma231d agoRoche — cobas® EGFR Mutation Test, v2.0 (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWD. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device pma231d agoRoche Molecular Systems, Inc. — cobsa® BRAF V600 Mutation Test (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWD. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device recall231d agoMedline Industries, LP device recall (Cls II)

Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081 — Reason: Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication. — Status: Ongoing

Dec 31, 2025device recall231d agoMiach Orthopaedics device recall (Cls II)

BEAR Implant. Model Number: 1000. — Reason: Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect. — Status: Ongoing

full page →fda device recalls ↗

Dec 31, 2025device recall231d agoMedica Corporation device recall (Cls II)

Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. — Reason: A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes. — Status: Ongoing

full page →fda device recalls ↗

Dec 31, 2025device recall231d agoCentinel Spine, Inc. device recall (Cls II)

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No — Reason: Products were mislabeled as the 6mm product but included the 5 mm product. — Status: Ongoing

full page →fda device recalls ↗

Dec 31, 2025grant231d agoVANDERBILT UNIVERSITY MEDICAL CENTER — Cerebral blood flow resistance mapping to identify amyloid-related imaging ab...

AG grant. $75,520. PI: Wesley T Richerson

full page →nih reporter ↗

Dec 31, 2025grant231d agoUNIVERSITY OF WASHINGTON — Understanding the mechanisms driving emergence of atypical age-associated thy...University of Washington

AG grant. $49,538. PI: Dante Dennis Verendia Acenas II

full page →nih reporter ↗

Jan 1, 2026grant230d agoUNIVERSITY OF PITTSBURGH AT PITTSBURGH — Morphogen signaling feedback and dynamics in embryonic patterning

HD grant. $49,538. PI: Alison Guyer

full page →nih reporter ↗

Jan 1, 2026grant230d agoUNIVERSITY OF CALIFORNIA LOS ANGELES — Proteomic determinants of response to checkpoint blockade in malignant pleura...University of California Los Angeles

CA grant. $407,412. PI: Bryan Michael Burt

full page →nih reporter ↗

Jan 1, 2026grant230d agoVETERANS HEALTH ADMINISTRATION — Precision-Medicine Diagnostic Support in Hospitalized Veterans with Acute Kid...

VA grant. PI: MICHAEL E. MATHENY

full page →nih reporter ↗

Jan 1, 2026grant230d agoHARVARD MEDICAL SCHOOL — Forebrain Representations and Control of Sniffing

DC grant. $82,540. PI: Byron Howard Price

full page →nih reporter ↗

Jan 1, 2026grant230d agoNORTHWESTERN UNIVERSITY AT CHICAGO — DISE - A universal kill code in health and diseaseNorthwestern University

AG grant. $457,112. PI: Marcus E. Peter

full page →nih reporter ↗

Jan 1, 2026grant230d agoUNIVERSITY OF SOUTHERN CALIFORNIA — Multiscale Modeling of Hippocampus Vulnerability to Alzheimer's Disease Neuro...University of Southern California

AG grant. $695,789. PI: Michael Bienkowski

full page →nih reporter ↗

Jan 1, 2026grant230d agoUNIVERSITY OF TEXAS AT AUSTIN — CFTR gene correction via targeted exon replacement

HL grant. $41,057. PI: Jesse Buffington

full page →nih reporter ↗

Jan 1, 2026grant230d agoBOSTON UNIVERSITY MEDICAL CAMPUS — Network biomarkers for early detection of cognitive impairment using digital ...

AG grant. $323,825. PI: Shariq Mohammed

full page →nih reporter ↗

Jan 1, 2026grant230d agoUNIVERSITY OF CALIFORNIA AT DAVIS — Taste perception of host cues in the invasive disease vector mosquito Aedes a...

DC grant. $238,502. PI: Lisa Soyeon Baik

full page →nih reporter ↗

Jan 1, 2026grant230d agoPENNSYLVANIA STATE UNIVERSITY, THE — Estimation of risk associated with zoonotic tuberculosis in South India

AI grant. $85,563. PI: Vivek Kapur

full page →nih reporter ↗

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Week of Dec 29, 2025