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tags : Fda    crawled date : 2021 - 12 - 01   

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Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO®
Published: 2021-12-01 (Crawled : 22:00) - biospace.com/
HALO M | $39.43 1.18% 210K |

Health Technology

| 18.52% | O: 0.58% H: 1.84% C: -2.72%
fda fda approval approval

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Inhibrx Receives FDA Orphan-Drug Designation for INBRX-109 in Chondrosarcoma
Published: 2021-12-01 (Crawled : 22:00) - biospace.com/
INBX | $34.12 -0.03% 67K |

Health Technology

| -15.58% | O: 1.31% H: 1.59% C: -1.73%
fda rosa drug designation

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U.S. FDA Approves DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
Published: 2021-12-01 (Crawled : 21:00) - biospace.com/
GNMSF | News | $290.34 340 |

Health Technology

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JNJ | News | $148.22 -0.9% 3.3M |

Health Technology

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GMAB | News | $28.12 -1.54% 170K |

Health Technology

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AMGN | News | $274.15 0.22% 900K |

Health Technology

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fda

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FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone For Patients With Multiple Myeloma At First Or Subsequent Relapse
Published: 2021-12-01 (Crawled : 19:00) - prnewswire.com
JNJ | News | $148.22 -0.9% 3.3M |

Health Technology

| -5.33% | O: -0.26% H: 0.0% C: 0.0%
BGNE | $142.065 2.21% 100K |

Health Technology

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AMGN | News | $274.15 0.22% 900K |

Health Technology

| 36.23% | O: -0.03% H: 1.18% C: 0.22%
fda

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Surface Oncology Announces FDA Clearance of IND Application for GSK4381562, a Novel Antibody Targeting PVRIGSurface to receive $30 million milestone payment upon first patient treated in the Phase 1 study
Published: 2021-12-01 (Crawled : 15:30) - biospace.com/
SURF | $1.07 -0.93% -1.41% 0 |

Health Technology

| -81.62% | O: 1.72% H: 0.0% C: 0.0%
fda clearance application fda clearance phase 1 antibody milestone

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FDA Reissues LumiraDx Fast Lab Solutions' EUA for SARS CoV-2 RNA STAR Complete Molecular Reagents to Allow High Throughput and Asymptomatic Testing Solutions
Published: 2021-12-01 (Crawled : 14:30) - biospace.com/
LMDX | $0.016 -15.0% 130M |

| -99.83% | O: 8.54% H: 3.01% C: -7.67%
fda test molecular sars-cov-2

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CytoDyn Submits CMC (Manufacturing) Section of HIV BLA to FDA Under Previously Authorized Rolling Review; Last (Clinical) Section Will Complete Full BLA Submission
Published: 2021-12-01 (Crawled : 14:00) - biospace.com/
CYDY | $0.15 420K |

Manufacturing

| -88.0% | O: 0.8% H: 1.98% C: -8.73%
fda authorized hiv submission bla submission

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BeyondSpring Pharmaceuticals Receives Complete Response Letter from the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-Induced Neutropenia (CIN)
Published: 2021-12-01 (Crawled : 14:00) - beyondspringpharma.com
BYSI | $2.44 6.55% 77K |

Health Technology

| -82.79% | O: -55.97% H: 8.19% C: -15.87%
new drug fda application drug therapy plinabulin

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Moleculin Receives FDA Allowance to Begin a Phase 1 Study of WP1122 for the Treatment of Glioblastoma Multiforme
Published: 2021-12-01 (Crawled : 13:30) - prnewswire.com
MBRX | $4.6 3.2K |

Health Technology

| 124.94% | O: 1.22% H: 10.14% C: 5.8%
treatment fda phase 1 phase 2 glioblastoma

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VBI Vaccines Announces FDA Approval of PreHevbrio™ for the Prevention of Hepatitis B in Adults
Published: 2021-12-01 (Crawled : 12:30) - vbivaccines.com
VBIV | $0.581 -4.52% 87K |

Health Technology

| -78.6% | O: 19.65% H: 0.15% C: -8.5%
fda hepatitis fda approval approval vaccine

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U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children
Published: 2021-12-01 (Crawled : 12:30) - biospace.com/
MRK | $126.585 -0.23% 2M |

Health Technology

| 69.63% | O: 0.98% H: 1.83% C: -1.44%
fda application license children vaccine fda acceptance pneumococcal

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Surface Oncology Announces FDA Clearance of IND Application for GSK4381562, a Novel Antibody Targeting PVRIG
Published: 2021-12-01 (Crawled : 12:30) - globenewswire.com
SURF | $1.07 -0.93% -1.41% 0 |

Health Technology

| -81.62% | O: 1.72% H: 0.0% C: 0.0%
fda clearance application fda clearance antibody pvrig

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BioXcel Therapeutics Announces Extension of FDA Review Period of its NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
Published: 2021-12-01 (Crawled : 12:30) - globenewswire.com
BTAI | News | $2.83 -4.71% 730K |

Health Technology

| -86.34% | O: -13.2% H: 11.23% C: 8.21%
treatment fda schizophrenia order therapeutics

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