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tags : Fda    entities : Amgen inc.    save search

Sandoz receives FDA approval for first and only denosumab biosimilars
Published: 2024-03-05 (Crawled : 19:00) - globenewswire.com
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
Health Technology
| | O: -0.46% H: 1.3% C: 0.44%

fda first approval
FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer
Published: 2023-12-13 (Crawled : 21:00) - prnewswire.com
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
Health Technology
| | O: 0.91% H: 2.03% C: 1.4%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: -0.11% H: 0.5% C: -1.78%

fda lung review cancer cell application grants advanced
AMGEN TO DISCUSS APPLICATION FOR LUMAKRAS® (SOTORASIB) FOR THE TREATMENT OF KRAS G12C-POSITIVE NSCLC AT FDA ADVISORY COMMITTEE MEETING
Published: 2023-08-21 (Crawled : 20:00) - prnewswire.com
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
Health Technology
| | O: -0.27% H: 0.99% C: -0.67%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
Health Technology
| | O: -0.18% H: 0.06% C: -1.01%

lumakras fda treatment meeting application
FDA GRANTS FULL APPROVAL FOR BLINCYTO® (BLINATUMOMAB) TO TREAT MINIMAL RESIDUAL DISEASE-POSITIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA
Published: 2023-06-21 (Crawled : 14:20) - biospace.com/
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
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| | O: -0.8% H: 0.36% C: -2.33%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: -0.18% H: 0.8% C: -0.5%

blincyto fda approval treat grants leukemia
Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA
Published: 2023-02-06 (Crawled : 07:00) - globenewswire.com
NVSEF | $93.6375 6.88% 82K twitter stocktwits trandingview |
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| | O: -0.44% H: 0.0% C: -2.93%
NVS | $92.57 -0.55% 0.0% 910K twitter stocktwits trandingview |
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| | O: -0.33% H: 0.15% C: -0.12%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: 0.08% H: 0.59% C: -0.62%

fda biosimilar application license
BridgeBio Pharma Announces First Lung Cancer Patient Dosed in Phase 1/2 Trial and US FDA Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with Amgen’s LUMAKRAS® (sotorasib)
Published: 2022-10-11 (Crawled : 12:00) - globenewswire.com
BMY | $48.3 0.96% -0.1% 11M twitter stocktwits trandingview |
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| | O: 0.12% H: 2.63% C: 1.59%
BBIO | $24.98 0.0% 2M twitter stocktwits trandingview |
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| | O: 1.06% H: 3.53% C: 0.95%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: 3.16% H: 4.59% C: 2.48%

bbp-398 lumakras fda designation lung pharma trial cancer fast track designation
Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis
Published: 2022-10-06 (Crawled : 12:00) - globenewswire.com
ENTX | $2.25 1.35% 1.33% 170K twitter stocktwits trandingview |
Health Technology
| | O: 7.62% H: 0.0% C: -7.08%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: -0.56% H: 0.27% C: -0.68%

eb613 treatment fda trial agreement osteoporosis
Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis- Total Hip BMD Established as Primary Endpoint -
Published: 2022-10-06 (Crawled : 12:00) - biospace.com/
ENTX | $2.25 1.35% 1.33% 170K twitter stocktwits trandingview |
Health Technology
| | O: 7.62% H: 0.0% C: -7.08%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: -0.56% H: 0.27% C: -0.68%

eb613 treatment fda trial agreement
FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
Published: 2022-06-06 (Crawled : 15:20) - biospace.com/
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
Health Technology
| | O: 7.48% H: 0.45% C: -4.8%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: -0.32% H: 0.2% C: -1.16%

rituxan fda biosimilar
Entera Bio Announces Successful EB613 End-of-Phase 2 Meeting with FDA
Published: 2022-01-04 (Crawled : 23:00) - biospace.com/
ENTX | $2.25 1.35% 1.33% 170K twitter stocktwits trandingview |
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| | O: 8.57% H: 0.0% C: -10.17%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: -0.41% H: 0.0% C: 0.0%

eb613 fda phase 2 613
Entera Bio Announces Successful EB613 End-of-Phase 2 Meeting with FDA: FDA Agrees to Phase 3 Twelve Month Study with Lumbar Spine BMD (bone mineral density) as the Primary Endpoint
Published: 2022-01-04 (Crawled : 14:00) - globenewswire.com
ENTX | $2.25 1.35% 1.33% 170K twitter stocktwits trandingview |
Health Technology
| | O: 8.57% H: 0.0% C: -10.17%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
Health Technology
| | O: -0.41% H: 0.0% C: 0.0%

eb613 fda phase 2 bone 613 spine phase 3
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 | $281.02 3.83% 210 twitter stocktwits trandingview |
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| | O: -0.54% H: 3.8% C: 2.35%
JNJ | News | $145.74 0.67% 0.0% 9.3M twitter stocktwits trandingview |
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| | O: -1.03% H: 2.04% C: 0.76%
GMAB | $28.32 -0.74% -0.74% 240K twitter stocktwits trandingview |
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| | O: 0.55% H: 0.59% C: -1.88%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: 0.78% H: 2.59% C: 0.18%

fda
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 | $145.74 0.67% 0.0% 9.3M twitter stocktwits trandingview |
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| | O: -0.26% H: 0.0% C: 0.0%
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
Health Technology
| | O: 0.69% H: 0.0% C: 0.0%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
Health Technology
| | O: -0.03% H: 1.18% C: 0.22%

fda
FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product’s benefit
Published: 2021-07-14 (Crawled : 19:26) - fda.gov
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: -0.15% H: 1.33% C: 0.94%

fda
Tezepelumab Granted Priority Review By U.S. FDA
Published: 2021-07-08 (Crawled : 07:00) - prnewswire.com
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
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| | O: -1.71% H: 4.93% C: 3.36%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: 0.42% H: 1.01% C: 0.02%

fda granted grant
QIAGEN Launches First FDA-approved Tissue Companion Diagnostic to Identify the KRAS G12C Mutation in NSCLC Tumours and Expand Precision Medicine Options in Lung Cancer
Published: 2021-05-28 (Crawled : 21:00) - biospace.com/
QGEN | $39.47 0.61% 0.0% 950K twitter stocktwits trandingview |
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| | O: 0.59% H: 0.91% C: -0.14%
QGEN | $39.47 0.61% 0.0% 950K twitter stocktwits trandingview |
Health Technology
| | O: 0.59% H: 0.91% C: -0.14%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
Health Technology
| | O: 0.38% H: 1.97% C: 0.73%

fda lung cancer cancer fda approval diagnostic
FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy
Published: 2021-05-28 (Crawled : 17:00) - prnewswire.com
GH M | $16.68 1.77% 1.74% 1.6M twitter stocktwits trandingview |
Health Services
| | O: 0.82% H: 2.28% C: -0.95%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: 0.38% H: 1.97% C: 0.73%

fda lung cancer therapy cancer drug fda approval approval
FDA Approves LUMAKRAS™ (Sotorasib), The First And Only Targeted Treatment For Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Published: 2021-05-28 (Crawled : 17:00) - prnewswire.com
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
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| | O: 0.41% H: 2.09% C: 1.72%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: 0.38% H: 1.97% C: 0.73%

treatment fda lung cancer cancer fda approval
Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA
Published: 2021-05-10 (Crawled : 16:00) - biospace.com/
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
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| | O: -0.63% H: 0.95% C: -2.15%
AZN | $68.36 -0.25% -0.25% 4M twitter stocktwits trandingview |
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| | O: 1.38% H: 0.27% C: -0.31%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: 0.7% H: 1.1% C: -1.32%

fda license application
FDA Accepts Amgen's Supplemental New Drug Application For Otezla® (apremilast) For Adults With Mild-To-Moderate Plaque Psoriasis
Published: 2021-05-05 (Crawled : 14:15) - biospace.com/
BGNE | $131.94 0.06% 0.06% 130K twitter stocktwits trandingview |
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| | O: -0.5% H: 3.2% C: -1.07%
AMGN | $262.77 -0.49% -0.49% 2M twitter stocktwits trandingview |
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| | O: -0.43% H: 1.5% C: 1.24%

new drug fda drug psoriasis fda acceptance application plague
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