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

By Nicholas Saraceno

November 23rd 2024

The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.

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PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy

By Feliza Mirasol

November 19th 2024

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

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

By Felicity Thomas

November 16th 2024

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

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

By Feliza Mirasol

November 8th 2024

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months.

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