FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|March 2, 2005
- Pharmaceutical Technology-03-02-2005
- Volume 29
- Issue 3
March 2005
Author(s)Pharmaceutical Technology Editors
pharmaceutical science and technology news
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Articles in this issue
over 21 years ago
Packaging Becomes Part of the Prescriptionover 21 years ago
Appraisal of the Laser Diffraction Particle-Sizing Techniqueover 21 years ago
Optimism Taking Over in Pharmaceutical Chemicalsover 21 years ago
In the Spotlight - March 2005over 21 years ago
A “Disclosure Defense” in Liability Lawover 21 years ago
Managing Aseptic Interventionsover 21 years ago
Validating Automated Systemsover 21 years ago
Combination Products Raise Manufacturing ChallengesAdvertisement
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Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
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