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August 12, 2022
Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.
Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.
August 10, 2022
FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.
Democrats approve curbs for Medicare plans, but not for commercial drug coverage.
August 09, 2022
The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.
August 04, 2022
Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.
August 02, 2022
FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.
FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.
August 01, 2022
The European Commission has approved Rinvoq (upadacitinib) for treatment of active non-radiographic axial spondyloarthritis.
The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.