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Recent Articles

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FDA grants priority review to AbbVie's SBLA for epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody for the treatment of adult relapsed or refractory follicular lymphoma; AbbVie and Genmab are co-developing epcoritamab

AstraZeneca ends collaboration with FibroGen on oral anemia drug roxadustat following FDA rejection, returns rights to the drug in the US and several other countries; AstraZeneca retains interest in China and South Korea where the drug has been approved

Catalent upgrades its capsule capacity to 300 million per year, one-third for potent drugs, at its Boston, Massachusetts, facility; the facility is a Global Center of Excellence for spray drying and DPI capsule manufacturing

J&J and Pharmacyclics receive FDA approval for oral suspension of IMBRUVICA to treat chronic lymphocytic leukemia /small lymphocytic lymphoma, Waldenström's macroglobulinemia, and chronic graft versus host disease

CHMP recommends approval of Bristol Myers' Reblozyl for adult patients with transfusion-dependent anemia due to myelodysplastic syndromes; if approved by the European Commission, it would represent the fourth authorized indication for Reblozyl in the EU

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