Calendar

pharmadog

Week of Mar 23, 2026

Mar 26, 2026approval145d agoKADCYLA (ADO-TRASTUZUMAB EMTANSINE) — FDA approvaltrastuzumab emtansine

Sponsor: GENENTECH. Form: VIAL. Route: SINGLE-USE

full page →trastuzumab emtansine →fda approvals ↗

Mar 26, 2026approval145d agoAWIQLI FLEXTOUCH (INSULIN ICODEC) — FDA approvalinsulin icodec

Sponsor: NOVO NORDISK INC. Form: INJECTION. Route: SOLUTION

full page →insulin icodec →fda approvals ↗

Mar 26, 2026approval145d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

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

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Mar 26, 2026approval145d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: ALEMBIC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 26, 2026approval145d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: ALEMBIC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 26, 2026approval145d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

Mar 26, 2026approval145d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Mar 26, 2026approval145d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Mar 26, 2026approval145d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 26, 2026device 510k145d agoLunit, Inc. — Lunit INSIGHT DBT (V1.2) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoMedtronic Navigation, Inc. — Stealth AXiS Cranial clinical application (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoVizaramed, Inc. — Multiflex Steerable Sheath 17.5F (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoSurgify Medical OY — Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoBIOMERIEUX — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoBlue Belt Technologies, Inc. — REAL INTELLIGENCE CORI (510k cleared)BETA Technologies, Inc.

Product code: OLO. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoDevilbiss Healthcare, LLC — DeVilbiss 5 Liter Oxygen Concentrator (555) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoShenzhen Urion Technology Co., Ltd. — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoAirs Medical, Inc. — SwiftMR (510k cleared)AVITA Medical, Inc.

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

full page →fda device 510k ↗

Mar 26, 2026device 510k145d agoRestore Robotics — Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device pma145d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

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

full page →fda device pma ↗

Mar 26, 2026device pma145d agoMedtronic Neuromodulation — Altaviva (PMA supplement)

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

full page →fda device pma ↗

Mar 26, 2026device pma145d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

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

full page →fda device pma ↗

Mar 26, 2026grant145d agoMEDICAL UNIVERSITY OF SOUTH CAROLINA — Data Analytics Training And Professional Development (DATA-Pro) for Behaviora...

CA grant. $215,976. PI: Kalyani Sonawane

full page →nih reporter ↗

Mar 26, 2026grant145d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — The Impact of Bile Salt Hydrolase on Intestinal T Cells in ColitisUniversity of California San Diego

DK grant. $43,313. PI: Elizabeth A Brown

full page →nih reporter ↗

Mar 26, 2026grant145d agoOREGON HEALTH & SCIENCE UNIVERSITY — A microphysiological model of prostate cancer metastasis into vascularized an...

CA grant. $521,002. PI: Luiz Eduardo Bertassoni

full page →nih reporter ↗

Mar 26, 2026grant145d agoOREGON HEALTH & SCIENCE UNIVERSITY — Direct and indirect MCL1 targeting for high-efficiency therapy of lung metast...

CA grant. $625,179. PI: Alexander E Davies

full page →nih reporter ↗

Mar 27, 2026approval144d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →epcoritamab →fda approvals ↗

Mar 27, 2026approval144d 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 27, 2026approval144d agoALLI (ORLISTAT) — FDA approvalH2-Pharma LLC

Sponsor: HALEON US HOLDINGS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval144d agoPONLIMSI (DENOSUMAB-ADET) — FDA approvalPONLIMSI

Sponsor: TEVA PHARMACEUTICALS, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →PONLIMSI →fda approvals ↗

Mar 27, 2026approval144d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →niraparib →fda approvals ↗

Mar 27, 2026approval144d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

full page →trofinetide →fda approvals ↗

Mar 27, 2026approval144d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 27, 2026approval144d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalATROPINE SULFATE

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

full page →ATROPINE SULFATE →fda approvals ↗

Mar 27, 2026approval144d agoASENAPINE MALEATE — FDA approvalASENAPINE MALEATE

Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: SUBLINGUAL

full page →ASENAPINE MALEATE →fda approvals ↗

Mar 27, 2026approval144d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Mar 27, 2026approval144d agoHALOPERIDOL DECANOATE — FDA approvalHALOPERIDOL DECANOATE

Sponsor: MANKIND PHARMA. Form: INJECTABLE. Route: INJECTION

full page →HALOPERIDOL DECANOATE →fda approvals ↗

Mar 27, 2026approval144d agoSPINRAZA (NUSINERSEN SODIUM) — FDA approvalBIOGEN INC.

Sponsor: BIOGEN IDEC. Form: SOLUTION. Route: INTRATHECAL

full page →fda approvals ↗

Mar 27, 2026approval144d agoLICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗

Mar 27, 2026approval144d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Mar 27, 2026approval144d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.