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Amphastar Pharmaceuticals, Inc.

http://www.amphastar.com

Latest From Amphastar Pharmaceuticals, Inc.

TORL Looks To Break Ground In Growing Field Of Claudin-Targeting Drugs

The company announced a series B-2 financing of $158m that it plans to use for pivotal Phase II development of TORL-1-23, which it called a first-in-class agent.

Financing Business Strategies

US Aspart Filing Kicks Off Amphastar’s Insulin Ambitions

Amphastar says a “milestone” submission of a US filing for insulin aspart underlines its ambitions in the diabetes segment. But could the firm get the first US biosimilar approval?

Biosimilars Strategy

‘Incremental’ Benefit Of Lumicell’s Cancer Imaging Drug Outweighs Manageable Risk, FDA Panel Says

Most advisory committee members supported approval of the breast cancer imaging product, but indicated labeling and advertising should be carefully crafted to avoid overhyping the likelihood patients experience a clinical benefit.

Advisory Committees Risk Management

Lumicell’s Cancer Imaging Drug Faces Clinical Meaningfulness, Anaphylaxis Risk Questions At FDA Panel

US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.

Advisory Committees FDA
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
    • Generic Drugs
    • OTC, Consumer
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Nasal
      • Pulmonary
  • Other Names / Subsidiaries
    • Amphastar France Pharmaceuticals (AFP)
    • Armstrong Pharmaceuticals, Inc.
    • International Medication Systems (IMS)
    • Nanjing Puyan Pharmaceutical Technology (ANP)
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