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June 8, 2023
TOKYO and CAMBRIDGE, Mass., June 8, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application for lecanemab (brand
June 8, 2023
FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants Nirsevimab would be the first immunization specifically designed to protect all... | June 8, 2023
June 8, 2023
FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants Nirsevimab would be the first immunization specifically designed to protect
June 8, 2023
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June 6, 2023
The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of dostarlimab plus chemotherapy for use in adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.
June 5, 2023
/PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and...
June 5, 2023
FDA Extending PDUFA Date by Three Months to Allow More Time to Complete Their Review; New PDUFA Date Set to November 27, 2023STAMFORD, Conn., June 05, 2023 -- SpringWorks Therapeutics, Inc. , a... | June 5, 2023
June 5, 2023
The FDA has extended the review period for the NDA for nirogacestat for the treatment of desmoid tumors.
June 1, 2023
The FDA has accepted for Priority Review the BLA for lifileucel, a one-time cell therapy, for advanced melanoma.