2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
News|Articles|May 1, 2003
- Pharmaceutical Technology-05-01-2003
- Volume 2003 Supplement
- Issue 2
The PQRI Aseptic Processing Working Group: What was it? What Did It Cover? What Conclusions Did It Reach? Why Was It Important?
Author(s)Glenn E. Wright
Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.
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The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
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