FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|May 2, 2005
- Pharmaceutical Technology-05-02-2005
- Volume 29
- Issue 5
New FDA Policies Shape Pharma Development and Production
Author(s)Jill Wechsler
FDA is finalizing guidances and enforcing compliance with manufacturing standards as part of its efforts to ensure drug safety.
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