Zilucoplan is a synthetic macrocyclic peptide approved by the Food and Drug Administration (FDA), in October 2023, for the treatment of generalized myasthenia gravis. It is considered as an orphan drug that causes the inhibition of terminal complement cascade activation with a dual mechanism of ...
Mounjaro, Relyvrio, and More: 9 New Drugs Approved in 2022 That You Should Know AboutWritten by Alyssa Billingsley, PharmD | Reviewed by Christina Aungst, PharmDPublished on March 7, 2023 print_outlinedemail_outlinedKey takeaways: In 2022, the FDA approved 37 novel (new) drugs. Over half...
1. FDA approves quizartinib for newly diagnosed acute myeloid leukemia. News release. July 20, 2023. Accessed July 20, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-quizartinib-newly-diagnosed-acute-myeloid-leukemia 2. Erba HP, Monetesinos P, Kim HJ, et al. Qui...
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. FDA. September 20, 2024. Accessed December 9, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-bortezomib-lenalidomide-and-dex...
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. FDA. September 20, 2024. Accessed November 15, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-bortezomib-lenalidomide-an...
The application of asciminib in newly diagnosed Ph+ CML in chronic phase has been granted priority review by the FDA.1 FDA priority review designation signals drugs that, if approved, would provide significant improvements to safety or efficacy over available treatments. With priority review, the ...
There is no antidote to the effects of xylazine, and the authors explain that xylazine contamination should be suspected when naloxone appears not to work effectively in people with opioid toxicity. Xylazine is not approved for use in humans and is increasingly found in illicit drug samples along...
Center is one of the first sites nationwide to have commercial access to TriClip and is the first hospital in Western United States to utilize the system since it was approved by the U.S. Food and Drug Administration (FDA). UC Davis also hosted clinical trials for the procedure in 2023. ...
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The FDA has set a Prescription Drug User Fee Act, or target action, date of January 20, 2024. The results are also being discussed with regulatory authorities worldwide. In the U.S., KEYTRUDA has two approved i...