followed by 21 anti-infective drugs and 12 CNS drugs. Notable approvals include two CAR-T products (equecabtagene autoleucel and inaticabtagene autoleucel) that were independently developed in China, mobocertinib as the first approved oral targeted therapy for advanced...
With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020–2021. As in previous years of this annual review, we assign these new drugs to one of three levels o...
With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approache...
FDA. Advancing health through innovation: 2018 new drug therapy approvals https://www.fda.gov/media/120357/download (2019). Chen, E. Y., Joshi, S. K., Tran, A. & Prasad, V. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical ...
Hansen, S. N. et al. RNA therapeutics for epilepsy: an emerging modality for drug discovery. Epilepsia 64, 3113–3129 (2023). Article CAS PubMed Google Scholar Street, J. S., Qiu, Y. & Lignani, G. Are genetic therapies for epilepsy ready for the clinic? Epilepsy Curr. 23, 245–...
Missed out on the latest clinical practice guidelines? Here's a list of all the guidelines and FDA drug approvals that were published during the last month.
Official answer: Migraine Treatment The newest novel drug (approved March 9, 2023) for the treatment of migraine is Zavzpret...
The United States Food and Drug Administration (US FDA) granted traditional approval for Leqembi (lecanemab-irmb) on July 6, 2023, for the treatment of AD [17]. The approval of this treatment not only affirms the pathophysiological significance of amyloid in AD but also marks a notable ...
Recombinant proteins and peptides have also maintained a robust revenue forecast, with sales expectations soaring by nearly $40 billion from 2019 to 2023. Some technologies that were leaders in 2019 have experienced slower growth in forecasted revenue. For example, gene therapy, the third-largest ca...
2023;16(2):293–302. Article CAS PubMed Google Scholar Kohan DE, Heerspink HJL. Fluid retention and heart failure in the PRECISION trial. Lancet. 2023;401(10385):1335. Article PubMed Google Scholar Desai AS, Webb DJ, Taubel J, Casey S, Cheng Y, Robbie GJ, et al. Zilebesiran,...