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June 16, 2022
The draft ICH Q9(R1) document details the importance of quality risk management principles.
The new draft guidance describes a standards recognition program for regenerative medicine therapies.
June 10, 2022
The European Commission has granted conditional marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for treating multiple myeloma.
The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.
June 09, 2022
Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.
June 08, 2022
FDA has approved GSK’s vaccine for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.
June 02, 2022
EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.
FDA will use virtual site visits even after resuming active inspections.
June 01, 2022
Manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers.
May 31, 2022
FDA once again is taking steps to facilitate the import of less costly prescription drugs.