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FDA Grants Approval to Kedrion to Produce PLGD-1 Therapeutic at Bolognana Plant

November 23rd 2024

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

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Pii Boosts Prefilled Syringe Capabilities with $3.6 Million Investment

November 23rd 2024

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PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy

November 19th 2024

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EMA’s CHMP Gives Positive Opinion for Use of Lecanemab in Early Alzheimer’s Disease

November 16th 2024

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J&J’s Balversa Gains MHRA Marketing Authorization as Monotherapy for Bladder Cancer

November 8th 2024

Steps Towards Demystifying Risk-Based Decision Making

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

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