CSL Limited
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Latest From CSL Limited
PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion
But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.
Pfizer’s Hemophilia A Gene Therapy Superior To Prophylaxis In Phase III
The company’s giroctocogene fitelparvovec, partnered with Sangamo, could compete with BioMarin’s hemophilia A gene therapy Roctavian, but longer-term data may be needed.
Stock Watch: Biotechs Sell The Family Silver
When loss-making biotech companies mix debt with sluggish sales, difficult options like restructuring and asset sales remain.
INTERACT Meeting Timing Remains Point Of Confusion
US FDA review divisions will determine whether the meeting is appropriate because there are no one-size-fits-all requirements.
Company Information
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- Pharmaceuticals
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Pharmaceuticals
- Vaccines
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Medical Devices
- Diagnostic Equipment & Supplies
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Diagnostic Imaging Equipment & Supplies
- Digital Imaging
- Other Names / Subsidiaries
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- bioCSL
- CSL Behring
- CSL Behring Mexico
- CSL Biotherapies
- CSL Bioplasma
- Seqirus
- Wuhan Zhong Yuan Rui De Biological Products
- Ruide
- Calimmune, Inc.
- Vitaeris Inc.
- Zenyth Therapeutics Ltd.
- CSL, Ltd.
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