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41 catalysts · 15 device 510k · 14 approval · 9 device pma · 3 grant · 1 earnings
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41 catalysts · 15 device 510k · 14 approval · 9 device pma · 3 grant · 1 earnings
Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION
Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: SINOTHERAPEUTICS INC. Form: TABLET. Route: ORAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: GENSCO. Form: FILM. Route: ORAL
Sponsor: LONG GROVE PHARMS. Form: POWDER. Route: INTRAVENOUS
Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL
Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HIH. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: FYA. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OBR. Advisory committee: Unknown. Type: Traditional
Product code: OSN. Advisory committee: Orthopedic. Type: Traditional
Product code: QSY. Advisory committee: Unknown. Type: Traditional
Product code: FLE. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: ONV. Advisory committee: SU. Decision: APPR
Supplement type: Real-Time Process. Product code: LKK. Advisory committee: HO. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: QPY. Advisory committee: PM. Decision: APPR
Supplement type: 30-Day Notice. Product code: SGV. Advisory committee: SU. Decision: OK30
Supplement type: Special (Immediate Track). Product code: OAY. Advisory committee: GU. Decision: APPR
Product code: MJO. Advisory committee: OR. Decision: APPR
AI grant. $111,645. PI: Ruvandhi Nathavitharana
GM grant. $400,881. PI: Tomer Stern
GM grant. $402,051. PI: CARLITO B LEBRILLA