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October 02, 2023
Government provides a spoonful of sugar, and genuine leadership, for good medicines.
September 26, 2023
The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.
September 25, 2023
VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.
September 21, 2023
Pfizer reports ritlecitinib is the first and only treatment for alopecia areata to selectively inhibit Janus kinase 3, and to treat patients as young as 12.
September 20, 2023
Otsuka Pharmaceutical Europe and Astex Pharmaceuticals have announced the approval of INAQOVI by the European Commission.
As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9.
Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.
Leaders at CDER and CBER give update on organizational changes at FDA.
September 19, 2023
The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.
The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.