Calendar

pharmadog

Week of Mar 16, 2026

Mar 19, 2026approval151d agoSINEMET CR (CARBIDOPA) — FDA approvalcarbidopa

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

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval151d agoCREXONT (CARBIDOPA) — FDA approvalOrganon & Co.

Sponsor: IMPAX. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval151d agoIMCIVREE (SETMELANOTIDE ACETATE) — FDA approvalsetmelanotide

Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS

full page →setmelanotide →fda approvals ↗

Mar 19, 2026approval151d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS

full page →fda approvals ↗

Mar 19, 2026approval151d agoSINEMET (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ORGANON. Form: TABLET. Route: ORAL

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval151d agoEPHEDRINE SULFATE — FDA approvalEPHEDRINE SULFATE

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INTRAVENOUS

full page →EPHEDRINE SULFATE →fda approvals ↗

Mar 19, 2026approval151d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

Sponsor: VIWIT PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 19, 2026device 510k151d agoArbor Endovascular, LLC — Willow 24 Guidewire (510k cleared)

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoVy Spine, LLC — DiversiVy Facet Screw System (510k cleared)

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoNipro Medical Corporation — ELISIO-H (510k cleared)

Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoMirco-Tech (Nanjing) Co., Ltd. — Disposable Distal Cap (510k cleared)

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoYamaha Motor Co., Ltd. — JWG-1 (510k cleared)Yamaha Motor Co., Ltd.

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoDiaDent Group International — Dia-X Sil Bite (510k cleared)PS International Group Ltd.

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoRadformation, Inc. — AutoContour (RADAC V5) (510k cleared)

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoSt. shine Optical Co., Ltd. — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoWuhan PHOMED Technology Company , Ltd. — CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) (510k cleared)

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoGeistlich Pharma AG — Derma-Gide (510k cleared)

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

full page →fda device 510k ↗

Mar 19, 2026device 510k151d agoLake Region Medical — Enroute 0.014'' Transcarotid Guidewire (510k cleared)

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

full page →fda device 510k ↗

Mar 19, 2026device pma151d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

Supplement type: Normal 180 Day Track. Product code: PLS. Advisory committee: PA. Decision: APPR

full page →fda device pma ↗

Mar 19, 2026device pma151d agoMedtronic Sofamor Danek USA, Inc. — INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: NEK. Advisory committee: OR. Decision: OK30

full page →fda device pma ↗

Mar 19, 2026device pma151d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

full page →fda device pma ↗

Mar 19, 2026device pma151d agoMedtronic, Inc. — INFUSE® Bone Graft (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NPZ. Advisory committee: DE. Decision: OK30

full page →fda device pma ↗

Mar 19, 2026device pma151d agoSenseonics, Incorporated — Eversense® Continuous Glucose Monitoring System (PMA supplement)Senseonics Holdings, Inc.

Supplement type: Normal 180 Day Track No User Fee. Product code: QCD. Advisory committee: CH. Decision: APPR

full page →fda device pma ↗

Mar 19, 2026device pma151d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

full page →fda device pma ↗

Mar 19, 2026device pma151d agoABBOTT MEDICAL — Amplatzer Amulet Left Atrial Appendage Occluder (PMA supplement)

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

full page →fda device pma ↗

Mar 19, 2026device pma151d agoThe Spectranetics Corp. — Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (PMA supplement)

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

full page →fda device pma ↗

Mar 19, 2026device pma151d agoMedtronic Sofamor Danek USA, Inc. — INFUSE® Bone Graft (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: MPW. Advisory committee: OR. Decision: OK30

full page →fda device pma ↗

Mar 19, 2026device pma151d agoProverum, Ltd. — ProVee System for BPH (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MER. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Mar 19, 2026grant151d agoUNIVERSITY OF COLORADO — Splicing-mediated dysregulation of interferon signaling in cancer

CA grant. $385,333. PI: Edward Bo-yi Chuong

full page →nih reporter ↗

Mar 19, 2026grant151d agoPURDUE UNIVERSITY — Dissecting the role of tumor suppressing microRNAs in angiosarcoma

CA grant. $437,654. PI: Jason A. Hanna

full page →nih reporter ↗

Mar 19, 2026grant151d agoUNIVERSITY OF CALIFORNIA-IRVINE — Harnessing Nutritional Modulation to Enhance Cancer Drug Potency

CA grant. $403,686. PI: Christopher J. Halbrook

full page →nih reporter ↗

Mar 19, 2026grant151d agoPORTERCARE ADVENTIST HEALTH SYSTEM — Fibrinolysis Dysfunction Impact on Graft Function in Liver Transplantation

HL grant. $74,631. PI: Hunter B Moore

full page →nih reporter ↗

Mar 20, 2026approval150d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 20, 2026approval150d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2026approval150d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2026approval150d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 20, 2026approval150d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗

Mar 20, 2026approval150d agoATONCY (ATOMOXETINE HYDROCHLORIDE) — FDA approvalPrasco LLC

Sponsor: MAP77. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 20, 2026approval150d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

Mar 20, 2026approval150d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

Sponsor: GLAXOSMITHKLINE LLC. Form: SUSPENSION. Route: ORAL

full page →atovaquone →fda approvals ↗

Mar 20, 2026approval150d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Mar 20, 2026approval150d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Mar 20, 2026approval150d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →adrenaline →fda approvals ↗

Mar 20, 2026approval150d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Mar 20, 2026approval150d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

Mar 20, 2026approval150d agoLIDOCAINE HYDROCHLORIDE — FDA approvalLaryng-O-Jet

Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL

full page →Laryng-O-Jet →fda approvals ↗

Mar 20, 2026device 510k150d agoIcu Medical, Inc. — ClaveQS Bag (510k cleared)ICU MEDICAL INC/DE

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

full page →fda device 510k ↗

Mar 20, 2026device 510k150d agoNexstim Oyj — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (510k cleared)

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

full page →fda device 510k ↗

Mar 20, 2026device 510k150d agoVoco GmbH — Bifix Veneer LC, Bifix Veneer Try-In (510k cleared)

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

full page →fda device 510k ↗

← prev

page 17 of 149

Week of Mar 16, 2026