Calendar

pharmadog

Week of Mar 16, 2026

Mar 16, 2026device 510k154d agoMedtronic Navigation, Inc. — Stealth AXiS ENT clinical application (510k cleared)

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

full page →fda device 510k ↗

Mar 16, 2026device 510k154d agoStryker Instruments — SurgiCount+ System (510k cleared)

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

full page →fda device 510k ↗

Mar 16, 2026device 510k154d agoSonio — Sonio Detect (v3) (510k cleared)

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

full page →fda device 510k ↗

Mar 16, 2026device 510k154d agoHealgen Scientific,, LLC — Healgen® Accurate Oral Fluid Drug Test (510k cleared)

Product code: DJC. Advisory committee: Clinical Toxicology. Type: Traditional

full page →fda device 510k ↗

Mar 16, 2026device 510k154d agoPerfuze, Ltd. — Millipede System (510k cleared)

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

full page →fda device 510k ↗

Mar 16, 2026device 510k154d agoBAAT Medical Products B.V. — SINEFIX (510k cleared)

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

full page →fda device 510k ↗

Mar 16, 2026device 510k154d agoVoronoi Health Analytics Incorporated — Data Analysis Facilitation Suite (DAFS) (510k cleared)

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

full page →fda device 510k ↗

Mar 16, 2026device 510k154d agoShenzhen Desida Technology Co., Ltd. — LED Light Therapy Mask (Models: T2, RLD10) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Mar 16, 2026device 510k154d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ulike Reglow Light Therapy Device (UM10) (510k cleared)

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

full page →fda device 510k ↗

Mar 16, 2026device pma154d agoIntera Oncology — MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

full page →fda device pma ↗

Mar 16, 2026device pma154d agoInspireMD, Ltd. — CGuard Prime Carotid Stent System (PMA supplement)InspireMD, Inc.

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

full page →fda device pma ↗

Mar 16, 2026device pma154d agoOrganox Limited — OrganOx metra® System (PMA supplement)

Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Mar 16, 2026grant154d agoH. LEE MOFFITT CANCER CTR & RES INST — A multimodal liquid biopsy assay to quantify androgen receptor’s somatic alte...

CA grant. $225,511. PI: Manish Kohli

full page →nih reporter ↗

Mar 16, 2026grant154d agoCOLUMBIA UNIVERSITY HEALTH SCIENCES — Elucidating the role of a long noncoding RNA in Inflammatory Bowel Disease (IBD)

DK grant. $587,470. PI: Sankar Ghosh

full page →nih reporter ↗

Mar 16, 2026grant154d agoUNIVERSITY OF FLORIDA — Identification of approved drugs for BDNF insufficiencyUniversity of Florida

NS grant. $423,750. PI: BAOJI XU

full page →nih reporter ↗

Mar 16, 2026grant154d agoUNIVERSITY OF WASHINGTON — Serotonin and dopamine dynamics during kappa opioid mediated aversionUniversity of Washington

DA grant. $46,988. PI: Micaela Vela Ruiz

full page →nih reporter ↗

Mar 16, 2026grant154d agoBECKMAN RESEARCH INSTITUTE/CITY OF HOPE — An exosome-based liquid biopsy assay for the non-invasive early detection of ...City of Hope

CA grant. $738,675. PI: Ajay Goel

full page →nih reporter ↗

Mar 16, 2026grant154d agoJOHNS HOPKINS UNIVERSITY — CHARACTERIZING FLAGELLAR MOTILITY IN THE CONTEXT OF HOST-MICROBE SYMBIOSISJohns Hopkins University

GM grant. $388,333. PI: Jonathan Lynch

full page →nih reporter ↗

Mar 16, 2026grant154d agoCALIFORNIA INSTITUTE OF TECHNOLOGY — k-mer based local uniqueness exploration

HG grant. $90,632. PI: Delaney Kalcey Sullivan

full page →nih reporter ↗

Mar 16, 2026grant154d agoICAHN SCHOOL OF MEDICINE AT MOUNT SINAI — Deciphering the genetic, functional, and therapeutic roles of TREM2 in diabet...

DK grant. $656,180. PI: Jia Fu

full page →nih reporter ↗

Mar 16, 2026grant154d agoUNIVERSITY OF TX MD ANDERSON CAN CTR — Mechanistic basis and therapeutic strategies for PPP2R1A mutation in gynecolo...

CA grant. $653,967. PI: Rugang Zhang

full page →nih reporter ↗

Mar 16, 2026grant154d agoUNIVERSITY OF MINNESOTA DULUTH — BRE-SPAD at the University of Minnesota DuluthUniversity of Minnesota

GM grant. $759,572. PI: Erik T Brown

full page →nih reporter ↗

Mar 16, 2026grant154d agoUNIVERSITY OF WASHINGTON — Developmental mechanisms underlying the functional diversification of facial ...University of Washington

HD grant. $46,685. PI: Riku Yasutomi

full page →nih reporter ↗

Mar 16, 2026grant154d agoGORDON RESEARCH CONFERENCES — 2026 Metals in Medicine Gordon Research Conference and Gordon Research Seminar

CA grant. $5,000. PI: Maria Contel

full page →nih reporter ↗

Mar 16, 2026grant154d agoUNIVERSITY OF SOUTH CAROLINA AT COLUMBIA — Recovery from Post-Stroke Aphasia With rTMS Targeting The Anterior Temporal L...

DC grant. $146,004. PI: Sophie Arheix-Parras

full page →nih reporter ↗

Mar 16, 2026grant154d agoUNITED STATES ASSOCIATION FOR THE STUDY OF PAIN, INC. — US Association for the Study of Pain Annual Scientific Meeting

AT grant. $60,000. PI: MICHAEL S GOLD

full page →nih reporter ↗

Mar 17, 2026approval153d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗

Mar 17, 2026approval153d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Mar 17, 2026approval153d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Mar 17, 2026approval153d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →(ivacaftor + lumacaftor) →fda approvals ↗

Mar 17, 2026approval153d agoICOTYDE (ICOTROKINRA HYDROCHLORIDE) — FDA approvalicotrokinra hydrochloride

Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

full page →icotrokinra hydrochloride →fda approvals ↗

Mar 17, 2026approval153d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗

Mar 17, 2026approval153d agoAK-FLUOR 25% (FLUORESCEIN SODIUM) — FDA approvalLong Grove Pharmaceuticals LLC

Sponsor: LONG GROVE PHARMS. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 17, 2026approval153d agoOXALIPLATIN — FDA approvalOXALIPLATIN

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INTRAVENOUS

full page →OXALIPLATIN →fda approvals ↗

Mar 17, 2026approval153d agoOXALIPLATIN — FDA approvalOXALIPLATIN

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INTRAVENOUS

full page →OXALIPLATIN →fda approvals ↗

Mar 17, 2026approval153d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →ivacaftor →fda approvals ↗

Mar 17, 2026approval153d agoPIROXICAM — FDA approvalNostrum Pharmaceuticals LLC

Sponsor: UNICHEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 17, 2026approval153d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →(ivacaftor + lumacaftor) →fda approvals ↗

Mar 17, 2026approval153d agoSYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →ivacaftor →fda approvals ↗

Mar 17, 2026approval153d agoLYNAVOY (LINERIXIBAT) — FDA approvallinerixibat

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →linerixibat →fda approvals ↗

Mar 17, 2026approval153d agoMICAFUNGIN SODIUM — FDA approvalMICAFUNGIN SODIUM

Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS

full page →MICAFUNGIN SODIUM →fda approvals ↗

Mar 17, 2026approval153d agoTOBRADEX ST (DEXAMETHASONE) — FDA approvalOCULAR THERAPEUTIX, INC

Sponsor: HARROW EYE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Mar 17, 2026approval153d agoGAMIFANT (EMAPALUMAB-LZSG) — FDA approvalSobi Inc

Sponsor: NOVIMMUNE S.A.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 17, 2026approval153d agoCOMBIGAN (BRIMONIDINE TARTRATE) — FDA approvalLumify

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

full page →Lumify →fda approvals ↗

Mar 17, 2026device 510k153d agoEncore Guards — enCore Impression Material (510k cleared)

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoTyto Care , Ltd. — Tyto Insights for Eardrum Bulging Detection (510k cleared)

Product code: SHL. Advisory committee: Ear, Nose, Throat. Type: Direct

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoCompal Electronics, Inc. — BreathePal Bilevel (GFM50-MD2201) (510k cleared)ARROW ELECTRONICS, INC.

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoStreck, LLC — MDx-Chex for BCY (510k cleared)

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoElesta S.P.A — LASER THERMAL THERAPY KIT (510k cleared)

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoBTL Industries, Inc. — BTL-785NEH (510k cleared)NL INDUSTRIES INC

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

full page →fda device 510k ↗

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Week of Mar 16, 2026