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Amgen, Inc.

http://www.amgen.com

Latest From Amgen, Inc.

Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Drug Review

Heron Overcomes Two CRLs To Win Zynrelef Approval In Post-Op Pain

The combination of bupivacaine and meloxicam will be priced at a discount to Exparel, with Heron predicting rapid uptake. Label limited to three surgery types, but analysts expect off-label use.

Approvals Pricing Strategies

Cervical Cancer Data Inject Fresh Life Into Sanofi's Libtayo

Libtayo is the first immunotherapy to demonstrate an improvement in OS, PFS and ORR in advanced cervical cancer and approval in this indication could kickstart its lackluster sales to date.

ImmunoOncology Clinical Trials

‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively

ANDA action rate dipped below the 90% mandate in second fiscal quarter, another illustration of the effect the pandemic and other issues have on US FDA’s generic drug assessment system.

Review Pathway Coronavirus COVID-19
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Abgenix
    • Amgen Astellas BioPharma K.K.
    • Amgen K.K.
    • Avidia
    • BioVex Group
    • Catherex, Inc.
    • deCODE Genetics
    • Dezima Pharma B.V.
    • Five Prime Therapeutics, Inc.
    • Ilypsa
    • Immunex Corporation
    • KAI Pharmaceuticals
    • Kirin-Amgen Inc.
    • Laboratorio Quimico Farmaceutico Bergamo Ltd
    • Micromet, Inc. (CancerVax Corporation)
    • Nuevolution AB
    • Nuevolution A/S
    • Onyx Pharmaceuticals, Inc. (Proteolix, Inc.)
    • Saga Investments LLC
    • Tularik
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