calendar

Mar 5, 2026grant163d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Mechanisms that regulate cellular responses to phosphate

GM grant. $429,000. PI: Lauren Elizabeth Surface

Mar 5, 2026grant163d agoPENNSYLVANIA STATE UNIVERSITY, THE — Investigating brain-body allostasis via longitudinal in vivo imaging

GM grant. $407,603. PI: Grayson Oren Sipe

Mar 5, 2026grant163d agoUNIVERSITY OF MARYLAND BALTIMORE — SGLT2 - Novel Molecular Mechanism of AQP4 Regulation

NS grant. $602,065. PI: J. Marc Simard

full page →risankizumab →fda approvals ↗

Mar 6, 2026approval162d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS

Mar 6, 2026approval162d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INJECTION

full page →risankizumab →fda approvals ↗

Mar 6, 2026approval162d agoQUDEXY XR (TOPIRAMATE) — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

Mar 6, 2026approval162d agoPYLARIFY TRUVU (PIFLUFOLASTAT F-18) — FDA approval

Sponsor: APHELION. Form: SOLUTION. Route: INTRAVENOUS

full page →Restasis →fda approvals ↗

Mar 6, 2026approval162d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

Mar 6, 2026approval162d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗

Mar 6, 2026approval162d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →tofacitinib citrate ER →fda approvals ↗

Mar 6, 2026approval162d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

Mar 6, 2026approval162d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →PHYTONADIONE →fda approvals ↗

Mar 6, 2026approval162d agoVITAMIN K1 (PHYTONADIONE) — FDA approvalPHYTONADIONE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

Mar 6, 2026approval162d agoVITAMIN K1 (PHYTONADIONE) — FDA approvalPHYTONADIONE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →PHYTONADIONE →fda approvals ↗

Mar 6, 2026approval162d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →SIPONIMOD →fda approvals ↗

Mar 6, 2026approval162d agoSIPONIMOD — FDA approvalSIPONIMOD

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

Mar 6, 2026approval162d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Mar 6, 2026approval162d agoSOTYKTU (DEUCRAVACITINIB) — FDA approvalBristol-Myers Squibb Co

Sponsor: BRISTOL. Form: TABLET. Route: ORAL

Mar 6, 2026approval162d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →NICARDIPINE HYDROCHLORIDE →fda approvals ↗

Mar 6, 2026approval162d agoNICARDIPINE HYDROCHLORIDE — FDA approvalNICARDIPINE HYDROCHLORIDE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

Mar 6, 2026approval162d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: PRINSTON INC. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Mar 6, 2026approval162d agoEVEROLIMUS — FDA approvalEVEROLIMUS

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →EVEROLIMUS →fda approvals ↗

Mar 6, 2026approval162d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: INJECTABLE. Route: INJECTION

full page →Restasis →fda approvals ↗

Mar 6, 2026approval162d agoEPRONTIA (TOPIRAMATE) — FDA approvaltopiramate ER

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →topiramate ER →fda approvals ↗

Mar 6, 2026approval162d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Restasis →fda approvals ↗

Mar 6, 2026approval162d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Mar 6, 2026device 510k162d agoTreace Medical Concepts, Inc. — Treace Medical Concepts (TMC) Screw Fixation System (510k cleared)TREACE MEDICAL CONCEPTS, INC.

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

Mar 6, 2026device 510k162d agoOlympus Medical Systems Corp. — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (510k cleared)

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

Mar 6, 2026device 510k162d agoTheramicro — TeKBrace Knotless Anchor (510k cleared)

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

Mar 6, 2026device 510k162d agoZhejiang Chuangxiang Medical Technology Co., Ltd. — Single use stone retrieval balloons (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

Mar 6, 2026device 510k162d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) (510k cleared)

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

Mar 6, 2026device 510k162d agoBunkerHill Health — Bunkerhill Contrast AVC (510k cleared)

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

Mar 6, 2026device 510k162d agoCalyxo, Inc. — CVAC Image Processor (510k cleared)

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

Mar 6, 2026device 510k162d agoAdeor Medical AG — Velocity Alpha MR High Speed Surgical Drill System (510k cleared)

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

Mar 6, 2026device 510k162d agoNano4imaging GmbH — EmeryGlide (EG18008901) (510k cleared)

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

Mar 6, 2026device 510k162d agoFord Medtech, LLC — JFord Speculum Sleeve (510k cleared)

Product code: HIB. Advisory committee: Obstetrics/Gynecology. Type: Traditional

Mar 6, 2026device 510k162d agoHudens Bio Co., Ltd. — BONTREE PLUS (510k cleared)

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

Mar 6, 2026device 510k162d agoBunkerHill Health — Bunkerhill Contrast CAC (510k cleared)

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

Mar 6, 2026device 510k162d agoDepuy Ireland UC — VELYS Hip Navigation (510k cleared)

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

Mar 6, 2026device 510k162d agoGuangzhou Haoyimai Trading Co., Ltd. — Water-based lubricant (510k cleared)

Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional

Mar 6, 2026device pma162d agoKestra Medical Technologies, Inc. — ASSURE Wearable Cardioverter Defibrillator (WCD) System (PMA supplement)KESTRA MEDICAL TECHNOLOGIES, LTD.

Supplement type: Normal 180 Day Track. Product code: MVK. Advisory committee: CV. Decision: APPR

Mar 6, 2026device pma162d agoEuclid Vision Corporation — Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NUU. Advisory committee: OP. Decision: APPR

Mar 6, 2026device pma162d agoMedtronic, Inc. — HV Splitter/ Adaptor kit (PMA supplement)Medtronic plc

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

Mar 6, 2026device pma162d agoBiomet Manufacturing Corp — Oxford Cementless Partial Knee System (PMA supplement)

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

Mar 6, 2026device pma162d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR I CD; Ev (PMA supplement)

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

Mar 6, 2026device pma162d agoABBOTT MEDICAL — TriClip G4 System (PMA supplement)

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

Mar 6, 2026device pma162d agoMedtronic Cardiac Rhythm Disease Management — SelectSecure Lead (PMA supplement)

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

Mar 6, 2026device pma162d agoMedtronic, Inc. — IN.PACT 018 Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: ONU. Advisory committee: CV. Decision: APPR

Mar 6, 2026device pma162d agoBoston Scientific — ENDOTAK RELIANCE / RELIANCE 4-FRONT pace/sense defibrillation leads (PMA supplement)BOSTON SCIENTIFIC CORP

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