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publishing date : 2021 - 12 - 01    tags : Fda   

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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 | $38.64 2.2% 2.15% 1.3M |

Health Technology

| 17.52% | 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 | $34.36 -0.26% -0.26% 220K |

Health Technology

| -15.11% | 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 | $290.38 3.83% 220 |

Health Technology

| -25.33% | O: -0.54% H: 3.8% C: 2.35%
JNJ | News | $147.91 1.49% -0.03% 9.6M |

Health Technology

| -6.69% | O: -1.03% H: 2.04% C: 0.76%
GMAB | $28.72 1.38% 1.36% 360K |

Health Technology

| -25.49% | O: 0.55% H: 0.59% C: -1.88%
AMGN | $269.03 2.39% 2.33% 3.4M |

Health Technology

| 35.22% | O: 0.78% H: 2.59% C: 0.18%
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 | $147.91 1.49% -0.03% 9.6M |

Health Technology

| -6.43% | O: -0.26% H: 0.0% C: 0.0%
BGNE | $129.51 -1.86% -1.89% 300K |

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| -63.2% | O: 0.69% H: 0.0% C: 0.0%
AMGN | $269.03 2.39% 2.33% 3.4M |

Health Technology

| 33.93% | 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 | $0.1509 0.06% 810K |

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 | $1.8 -2.21% 80K |

Health Technology

| -85.65% | 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 | $4.65 2.8% 2.72% 11K |

Health Technology

| 127.38% | 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 | $0.6396 1.57% 1.55% 160K |

Health Technology

| -77.89% | 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 | News | $125.78 0.44% 0.0% 8.4M |

Health Technology

| 68.16% | 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 | $2.77 8.63% 7.94% 620K |

Health Technology

| -87.36% | O: -13.2% H: 11.23% C: 8.21%
treatment fda schizophrenia order therapeutics

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