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7,487 catalysts · 3,312 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
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7,487 catalysts · 3,312 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
Supplement type: Normal 180 Day Track. Product code: NVY. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
NS grant. $137,687. PI: Jelly Hubertus Maria Soffers
GM grant. $393,250. PI: Liana Twardosz Burghardt
HL grant. $1,151,500. PI: Ira A Tabas
MH grant. $2,305,031. PI: Andre Berndt
GM grant. $617,574. PI: Kathleen Collins
GM grant. $300,872. PI: Wentao Li
Sponsor: AYTU. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL
Sponsor: KINIKSA PHARMACEUTICALS (UK), LTD.. Form: VIAL. Route: SINGLE-USE
Sponsor: NEXTWAVE PHARMS. Form: TABLET, EXTENDED RELEASE, CHEWABLE. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: INNOGENIX. Form: TABLET. Route: ORAL
Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION
Sponsor: BAYER. Form: TABLET. Route: ORAL
Sponsor: P AND L. Form: GEL. Route: TOPICAL
Sponsor: SPRINGWORKS. Form: TABLET. Route: ORAL
Sponsor: DIFGEN PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: NVK. Advisory committee: General, Plastic Surgery. Type: Traditional
Advisory committee: Unknown. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: ELC. Advisory committee: Dental. Type: Traditional
Product code: MAF. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NIP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PJG. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. — Reason: During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements. — Status: Ongoing
AA grant. $249,000. PI: Bryan Cruz
MH grant. $990,550. PI: Susan Faja
MH grant. $431,750. PI: Michael Roland Williams
HL grant. $249,000. PI: Tetsushi Nakao
GM grant. $421,737. PI: Sarah Kostinski
MH grant. $800,384. PI: Vikaas Singh Sohal
EB grant. $174,861. PI: Theodora E Wingert
HL grant. $445,000. PI: Sahand Hormoz
HL grant. $53,507. PI: Nathalie Chen
MH grant. $1,611,088. PI: Zhuhao Wu
NS grant. $415,717. PI: Darcie Leann Moore
GM grant. $487,287. PI: Akhilesh Basi Reddy
GM grant. $94,154. PI: Lisa Jaremka