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Sep 24, 2025grant329d agoGEORGIA STATE UNIVERSITY — Transgenic mouse models of disease to test an innovative OMV-based vaccine fo...

AI grant. $300,744. PI: CYNTHIA N CORNELISSEN

Sep 24, 2025grant329d agoPARAMITA THERAPEUTICS, INC. — Novel multivalent PSMA-targeted taxane-conjugates for bone metastases in pros...

CA grant. $353,009. PI: Sang Van

Sep 24, 2025grant329d agoORPRO THERAPEUTICS, INC. — Engineered Monothiol Thioredoxin for Treatment of Radiation Induced Lung Injury

HL grant. $508,988. PI: Peter B Heifetz

Sep 24, 2025grant329d agoOREGON HEALTH & SCIENCE UNIVERSITY — In vivo investigations of astrocyte-oligodendrocyte interactions

NS grant. $429,000. PI: Kelly R Monk

Sep 24, 2025grant329d agoSIBEL INC. — Novel AI-Enabled Wearable Sensor for Scratch Monitoring

FD grant. $249,999. PI: Shuai Xu

Sep 24, 2025grant329d agoLOCUS BIOSCIENCES, INC. — Development of Therapeutic Candidates for Antibiotic Resistant BacteriaLocus Biosciences Inc

AI grant. $3,318,955. PI: Paul Joon Kim

Sep 24, 2025grant329d agoZENVAX, LLC — Use a humanized monoclonal antibody as an emergency prophylactic and therapeu...

AI grant. $301,674. PI: Guoquan Zhang

Sep 24, 2025grant329d agoVENA VITALS, INC. — Continuous Non-Invasive Blood Pressure during Sleep as a Cardiovascular Bioma...

HL grant. $306,872. PI: Joshua Kim

Sep 24, 2025grant329d agoLEIDOS BIOMEDICAL RESEARCH, INC. — FY25 TO-H W3F1 RENOVATIONS

CA grant. $1,856,809. PI: lynn briscoe

full page →inavolisib →fda approvals ↗

Sep 25, 2025approval328d agoITOVEBI (INAVOLISIB) — FDA approvalinavolisib

Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL

Sep 25, 2025approval328d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

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

full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗

Sep 25, 2025approval328d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Sep 25, 2025approval328d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Sep 25, 2025approval328d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗

Sep 25, 2025approval328d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →ivacaftor →fda approvals ↗

Sep 25, 2025approval328d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

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

Sep 25, 2025approval328d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗

Sep 25, 2025approval328d agoSYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approvalivacaftor

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

full page →ivacaftor →fda approvals ↗

Sep 25, 2025approval328d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

Sep 25, 2025approval328d agoROBINUL (GLYCOPYRROLATE) — FDA approvalGLYCOPYRROLATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →GLYCOPYRROLATE →fda approvals ↗

Sep 25, 2025approval328d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

Sep 25, 2025approval328d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

Sep 25, 2025approval328d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

Sep 25, 2025approval328d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

Sep 25, 2025approval328d agoINLURIYO (IMLUNESTRANT TOSYLATE) — FDA approvalimlunestrant tosylate

Sponsor: ELI LILLY AND CO. Form: TABLET. Route: ORAL

full page →imlunestrant tosylate →fda approvals ↗

Sep 25, 2025approval328d agoCEFUROXIME AXETIL — FDA approvalOrchid Pharma Inc

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

Sep 25, 2025approval328d agoCEFUROXIME AXETIL — FDA approvalOrchid Pharma Inc

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

Sep 25, 2025approval328d agoCEFUROXIME AXETIL — FDA approvalOrchid Pharma Inc

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →paltusotine hydrochloride →fda approvals ↗

Sep 25, 2025approval328d agoPALSONIFY (PALTUSOTINE HYDROCHLORIDE) — FDA approvalpaltusotine hydrochloride

Sponsor: CRINETICS. Form: TABLET. Route: ORAL

Sep 25, 2025approval328d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Sep 25, 2025approval328d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Sep 25, 2025approval328d agoEVKEEZA (EVINACUMAB-DGNB) — FDA approvalevinacumab

Sponsor: REGENERON PHARMACEUTICALS. Form: SOLUTION. Route: INJECTION

full page →evinacumab →fda approvals ↗

Sep 25, 2025approval328d agoRIVAROXABAN — FDA approvalRIVAROXABAN

Sponsor: LUPIN LTD. Form: FOR SUSPENSION. Route: ORAL

full page →RIVAROXABAN →fda approvals ↗

Sep 25, 2025device 510k328d agoBistos Co., Ltd. — Hi bebe super (BT-150B) (510k cleared)

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

Sep 25, 2025device 510k328d agoHologic — Panther Fusion GI Bacterial Assay (510k cleared)

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

Sep 25, 2025device 510k328d agoJdentalcare Srl — JDEvolution Plus L and JDEvolution Plus LE (510k cleared)

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

Sep 25, 2025device 510k328d agoAbbott Molecular, Inc. — Alinity m HCV (510k cleared)

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

Sep 25, 2025device 510k328d agoCovidien, LLC — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced (510k cleared)

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

Sep 25, 2025device 510k328d agoOlympus Medical Systems Corporation — Single-Use Biopsy Valve (MAJ-1555) (510k cleared)

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

Sep 25, 2025device 510k328d agoWuhan Dimed Laser Technology Co., Ltd. — Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (510k cleared)

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

Sep 25, 2025device 510k328d agoShanghai Berry Electronic Tech Co., Ltd. — Pulse Oximeter (510k cleared)

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

Sep 25, 2025device 510k328d agoHologic, Inc. — Panther Fusion GI Expanded Bacterial Assay (510k cleared)

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

Sep 25, 2025device 510k328d agoEnpuno Biotechnology Co., Ltd. — Root canal repair materials (nRoot BP) (510k cleared)TaiGen Biotechnology Co Ltd

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

Sep 25, 2025device 510k328d agoABBOTT MEDICAL — EnSite X EP System (510k cleared)

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

Sep 25, 2025device 510k328d agoShanghai United Imaging Healthcare Co., Ltd. — uMR 680 (510k cleared)

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

Sep 25, 2025device 510k328d agoNeuravi Limited — EMBOTRAP III Revascularization Device (510k cleared)

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

Sep 25, 2025device 510k328d agoInnovasis — Endeavor Stand-Alone Cervical IBF System (510k cleared)

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

Sep 25, 2025device 510k328d agoMagnolia Medical Technologies — Steripath® Flow Blood Collection System (510k cleared)Medical Care Technologies Inc.

Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional

Sep 25, 2025device 510k328d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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