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August 12, 2021
The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.
Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.
August 11, 2021
The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.
Datwyler offers the StarterPack packaging system designed to aid in the development of parenteral drug packaging.
August 10, 2021
The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.
August 09, 2021
Kyowa Pharmaceutical Industry and Bora Pharmaceuticals have announced a partnership to produce generic-drug product for filing in Japan.
Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.
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.