Latest From Celltrion Inc.
Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.
Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions written record; negotiations for BsUFA III may be opportunity to create such a process.
Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
Mylan and Biocon have launched their Ogivri trastuzumab biosimilar in the US, marking the second biosimilar rival to Herceptin and leading a new wave of trastuzumab biosimilars expected to arrive in the US early next year.
- Large Molecule
- Contract Research, Toxicology Testing-CRO
- Generic Drugs
- Therapeutic Areas
- Immune Disorders
- Infectious & Viral Diseases
- Musculoskeletal & Connective Tissue Disorders
- Respiratory, Pulmonary
- South Korea
- Pacific Rim
- Parent & Subsidiaries
- Celltrion Inc.
- Senior Management
- Hyoung-Ki Kim, Co-CEO
- Contact Info
Phone: (82) 32 850 5000
Incheon City, 406-840
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