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Establishing a quality culture ensures a safe and effective product, and saves costs.
Data may be used to improve (or remove) a corrective action/preventive action.
Testing various tablet-splitting devices showed how well they performed.
August 16, 2022
Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.
The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.
August 15, 2022
The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.
August 12, 2022
Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.
Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.
Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.
August 11, 2022
Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.
August 10, 2022
FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.
Democrats approve curbs for Medicare plans, but not for commercial drug coverage.