Calendar

pharmadog

Week of Dec 1, 2025

Dec 1, 2025approval261d agoOMLYCLO (OMALIZUMAB-IGEC) — FDA approvalomalizumab biosimilar

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

full page →omalizumab biosimilar →fda approvals ↗

Dec 1, 2025approval261d agoALBUTEROL SULFATE — FDA approvalGlaxoSmithKline LLC

Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION

full page →fda approvals ↗

Dec 1, 2025device 510k261d agoExactech, Inc. — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (510k cleared)

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

full page →fda device 510k ↗

Dec 1, 2025device 510k261d agoShenzhen Suyzeko Limited. — Led Light Phototherapy Bed (Pro 450/ GY-680A) (510k cleared)

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

full page →fda device 510k ↗

Dec 1, 2025device 510k261d agoDrägerwerk AG & Co. KGaA — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) (510k cleared)

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

full page →fda device 510k ↗

Dec 1, 2025device 510k261d agoCanon Medical Systems Corporation — Cartesion Prime (PCD-1000A/3) V10.21 (510k cleared)

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

full page →fda device 510k ↗

Dec 1, 2025device 510k261d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) (510k cleared)

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

full page →fda device 510k ↗

Dec 1, 2025device 510k261d agoSpinal Simplicity, LLC — Minuteman® G6 MIS Fusion Plate (510k cleared)

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

full page →fda device 510k ↗

Dec 1, 2025device 510k261d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) (510k cleared)

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

full page →fda device 510k ↗

Dec 1, 2025device pma261d agoBoston Scientific Corp — WOLVERINE Coronary Cutting Balloon (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Dec 1, 2025device pma261d agoAbbott — CentriMag Circulatory Support System (PMA supplement)

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

full page →fda device pma ↗

Dec 1, 2025grant261d agoHARVARD UNIVERSITY — Tolloid Protease-Mediated Regulation of GDF11 in the Pathogenesis of Atrial F...

HL grant. $75,520. PI: Hannah Kelsey Fandl

Week of Dec 1, 2025