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August 09, 2021
The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.
EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.
KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.
FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.
AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.
August 06, 2021
Syntec receives warning letter where FDA finds deviations from CGMP for APIs.
BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.
Novavax and European Commission have finalized an agreement to purchase up to 200 million doses of a COVID-19 vaccine.
Metrics Contract Services announces the completion of a $10 million expansion to their Greenville, NC facilities.