Regulatory
Servier Pharmaceuticals’ vorasidenib on Tuesday secured the FDA’s green light for the treatment of patients with grade 2 gliomas carrying mutations in the IDH gene.
Lobbying groups and individuals connected with the industry are supporting candidates from both parties, with a particular focus on the future of the 340B discount program and pharmacy benefit managers.
With U.S. election season now in full swing, BioSpace looks at pharmaceutical-associated campaign contributions. Plus, Q2 earnings, Adaptimmune’s big approval, an anticipated FDA decision on an MDMA-assisted treatment and more.
In this live panel discussion, speakers focused on the EU AI Act’s global regulatory implications for medical devices & QARA’s future. An executive summary is available.
In this live panel discussion, speakers navigate integrated ecosystems and the future of QARA. An executive summary is available.
In this live panel discussion, speakers explore artificial intelligence in medtech and practical realities in QARA. An executive summary is available.
The FDA is looking for stronger overall survival data to back Actinium’s application for Iomab-B, an investigational therapy that will allow acute myeloid leukemia patients to receive bone marrow transplants.
An FDA advisory committee agreed on Friday that Zevra Therapeutics had provided sufficient efficacy data supporting the approval of arimoclomol for Niemann-Pick disease type C.
GSK, Moderna and Pfizer are all looking at potential respiratory syncytial virus vaccine sales slumps thanks to recently updated CDC guidelines regarding the use of RSV shots in seniors.
Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics.
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