Calendar

Week of Mar 16, 2026

Mar 18, 2026device pma152d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator) (PMA supplement)

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Mar 18, 2026device pma152d agoMerz North America, Inc. — COAPTITE® Injectable Implant (PMA supplement)

Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Mar 18, 2026device pma152d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Mar 18, 2026device pma152d agoCooperVision, Inc. — Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio (PMA supplement)

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

full page →fda device pma ↗

Mar 18, 2026device pma152d agoLivaNova USA, Inc. — aura6000 system (PMA)

Product code: MNQ. Advisory committee: AN. Decision: APPR

full page →fda device pma ↗

Mar 18, 2026device pma152d agoCarl Zeiss Meditec Production, LLC — CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P (PMA supplement)

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

full page →fda device pma ↗

Mar 18, 2026grant152d agoCALIFORNIA STATE UNIVERSITY NORTHRIDGE — Expanding Access to Digital Health Technologies Through Equity-Centered Engin...

EB grant. $21,072. PI: Thomas Chan

full page →nih reporter ↗

Mar 18, 2026grant152d agoSMITH COLLEGE — Effects of children's early experience with varying parental styles on the ne...

HD grant. $527,648. PI: Maya Rosen

full page →nih reporter ↗

Mar 18, 2026grant152d agoDUKE UNIVERSITY — Mechanisms of microbial regulation of postnatal growth and lipid metabolismDuke University

DK grant. $612,587. PI: Noelle Elizabeth Younge

full page →nih reporter ↗

Mar 18, 2026grant152d agoMASSACHUSETTS INSTITUTE OF TECHNOLOGY — Life-spanning study of Polycomb regulation by cohesin

AG grant. $51,038. PI: Emily Navarrete

full page →nih reporter ↗

Mar 18, 2026grant152d agoUNIVERSITY OF CONNECTICUT SCH OF MED/DNT — Investigating Dead Cell-Phagocyte Interaction at the Phagosomal Interface to ...

GM grant. $423,352. PI: Kai Li

full page →nih reporter ↗

Mar 18, 2026grant152d agoJOHNS HOPKINS UNIVERSITY — Mechanobiological regulations of collective cell movement: insights from in v...Johns Hopkins University

GM grant. $412,124. PI: Shinuo Weng

full page →nih reporter ↗

Mar 18, 2026grant152d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Targeting Lethal mCRPC with siRNA TherapeuticsUniversity of California San Diego

CA grant. $410,933. PI: STEVEN F DOWDY

full page →nih reporter ↗

Mar 18, 2026grant152d agoUNIVERSITY OF PITTSBURGH AT PITTSBURGH — Epigenetic Regulation of Hypothalamic Energy Homeostasis

DK grant. $664,240. PI: Isin Cakir

full page →nih reporter ↗

Mar 18, 2026grant152d agoAUBURN UNIVERSITY AT MONTGOMERY — BRE-SPAD at Auburn University at Montgomery

GM grant. $554,945. PI: Douglas W Leaman

full page →nih reporter ↗

Mar 18, 2026grant152d agoUNIVERSITY OF PITTSBURGH AT PITTSBURGH — Novel targeted combinatorial therapy for castration-resistant prostate cancer

CA grant. $658,492. PI: Song Li

full page →nih reporter ↗

Mar 18, 2026grant152d agoUT SOUTHWESTERN MEDICAL CENTER — Lipid Droplets

DK grant. $25,000. PI: Mike Henne

full page →nih reporter ↗

Mar 18, 2026grant152d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Progressive Clinical Team-Based Design and Skill-Building Across All Undergra...University of California San Diego

EB grant. $21,600. PI: Reem Khojah

full page →nih reporter ↗

Mar 18, 2026grant152d agoSTANFORD UNIVERSITY — Threading the needle: Development of Novel MR Methods for Effective Control o...Stanford University

CA grant. $593,557. PI: Lawrence D Recht

full page →nih reporter ↗

Mar 18, 2026grant152d agoUNIVERSITY OF MARYLAND BALTIMORE — Associations between actigraphy-derived circadian rest-activity rhythms and c...

CA grant. $411,334. PI: Amber Simmons Kleckner

full page →nih reporter ↗

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

Sponsor: ABBVIE. Form: SUSPENSION. Route: ENTERAL

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval151d agoRIFAXIMIN — FDA approvalSalix Pharmaceuticals Ltd

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval151d agoRIFABUTIN — FDA approvali3 Pharmaceuticals LLC

Sponsor: I3 PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval151d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

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

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval151d agoVYALEV (FOSCARBIDOPA) — FDA approval(foscarbidopa + foslevodopa)

Sponsor: ABBVIE. Form: SOLUTION. Route: SUBCUTANEOUS

full page →(foscarbidopa + foslevodopa) →fda approvals ↗

Mar 19, 2026approval151d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval151d agoOPUVIZ (AFLIBERCEPT-YSZY) — FDA approvalOPUVIZ

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →OPUVIZ →fda approvals ↗

Mar 19, 2026approval151d agoVALGANCICLOVIR HYDROCHLORIDE — FDA approvalVALGANCICLOVIR HYDROCHLORIDE

Sponsor: MICRO LABS. Form: FOR SOLUTION. Route: ORAL

full page →VALGANCICLOVIR HYDROCHLORIDE →fda approvals ↗

Mar 19, 2026approval151d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Mar 19, 2026approval151d agoFLAVALTA (EPINEPHRINE BITARTRATE) — FDA approvalDe Motu Cordis Pty Ltd

Sponsor: DEPROCO. Form: SOLUTION. Route: INJECTION

full page →fda approvals ↗

Mar 19, 2026approval151d agoDHIVY (CARBIDOPA) — FDA approvalAvion Pharmaceuticals LLC

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

full page →fda approvals ↗

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

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

full page →fda approvals ↗

Mar 19, 2026approval151d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Mar 19, 2026approval151d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Mar 19, 2026approval151d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

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 ↗

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Week of Mar 16, 2026