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Priority FDA review given to AstraZeneca’s Imfinzi sBLA for MIBC
The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca's supplemental biologics licence application (sBLA) for Imfinzi (durvalumab), a human monoclonal antibody ...
Monthly Prescribing Reference4d
Novel Therapy for Pyruvate Dehydrogenase Complex Deficiency Gets Priority Review
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for SL1009 (sodium dichloroacetate oral solution) for the treatment of pyruvate dehydrogenase complex ...
Targeted Oncology5d
FDA Grants Belzutifan Priority Review For Advanced Pheochromocytoma and Paraganglioma
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
Merck: FDA grants priority review to sNDA for Welireg
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
Pharm Exec6d
FDA Grants Priority Review to Merck’s Welireg for Advanced, Unresectable, or Metastatic Pheochromocytoma, Paraganglioma
Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and ...
Merck Gets FDA Priority Review of Welireg in Rare Adrenal Tumors
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the ...
Cure Today20d
FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC
Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. The WU-KONG1 Part B study showed a 53.3% objective response ...
Morningstar21d
Datopotamab Deruxtecan Granted Priority Review in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating ...
Monthly Prescribing Reference6d
Belzutifan Gets Priority Review for Advanced Pheochromocytoma and Paraganglioma
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...
Morningstar6d
Merck Gets FDA Priority Review of Welireg in Rare Adrenal Tumors
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around ...