calendar
7,525 catalysts · 3,350 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
7,525 catalysts · 3,350 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION
Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION
Sponsor: DEXCEL. Form: FOR SOLUTION. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: FOR SOLUTION. Route: ORAL
Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL
Sponsor: ANNORA PHARMA. Form: TABLET. Route: ORAL-28
Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INJECTION
Sponsor: ORGANON. Form: TABLET. Route: ORAL
Sponsor: INVAGEN PHARMS. Form: FOR SOLUTION. Route: ORAL
Sponsor: GENENTECH. Form: POWDER. Route: INTRAVENOUS
Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL
Sponsor: CARNEGIE. Form: TABLET. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: FOR SOLUTION. Route: ORAL
Sponsor: PYROS PHARMS. Form: SOLUTION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GRANULES. Form: FOR SOLUTION. Route: ORAL
Sponsor: DEXCEL. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 — Reason: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. — Status: Ongoing
Product code: MGZ. Advisory committee: Cardiovascular. Type: Special
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: LBH. Advisory committee: Dental. Type: Traditional
Product code: HJO. Advisory committee: Ophthalmic. Type: Traditional
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
EB grant. $21,072. PI: Thomas Chan
HD grant. $527,648. PI: Maya Rosen
DK grant. $612,587. PI: Noelle Elizabeth Younge
AG grant. $51,038. PI: Emily Navarrete
GM grant. $423,352. PI: Kai Li
GM grant. $412,124. PI: Shinuo Weng
CA grant. $410,933. PI: STEVEN F DOWDY
DK grant. $664,240. PI: Isin Cakir
GM grant. $554,945. PI: Douglas W Leaman