As of the end of May 2023, Medicilon has successfully assisted in the clinical approval of 7 GLP-1 drugs (3 approved by FDA and NMPA,1 approved by FDA, NMPA, and TGA) and has multiple GLP-1 projects under development. GLP-1 Glucagon like peptide-1 (GLP-1) is the second incretin ...
2022年上半年FDA批准新药多样化!癌症药一般, 糖尿病重磅药, 孤儿药,RNAi和同位素药16 novel drugs were approved by the FDA's Center for Drug Evaluation and Research (CDER) for the first half of the year (by Chris De Savi) - Oteseconazole (Vivjoa), an oral anti-fungal CYP51 ...
Exenatide (Byetta; Eli Lilly & Co), a synthetic GLP-1 receptor agonist suitable for twice daily s.c. injection, has now been approved by the FDA for the add-on therapy of patients with type 2 diabetes with insufficient metabolic control during metformin and/or sulfonylurea treatment. A ...
The FDA approved Trodelvy based on the results of a clinical trial of 108 patients with metastatic triple-negative breast cancer who had received at least two prior treatments for metastatic disease. The efficacy of Trodelvy was based on the ov...
To say GLP-1 drugs have potential beyond weight loss is an understatement. But there haven’t been any large-scale studies to move beyond the exciting (but limited) anecdotal data – and the plural of anecdote isn’t data. Without solid data, the FDA can’t add any of these potentially...
People with Obesity are getting the shaft from the FDA. That’s got to change. It is likely to come as a surprise that, considering all the attention and headlines about the America’s obesity epidemic and GLP-1 drugs such as Ozempic, Zepbound, and Mounjaro, that the FDA does not rout...
(lb). InSURPASS-2 trials, participants with type 2 diabetes received the same dosages of tirzepatide as in the previous trial or a 1-mg dosage ofsemaglutideonce weekly for 40 weeks. Semaglutide is an FDA-approved GLP-1 agonist used to treat type 2 diabetes. Tirzepatide reduced A1C from...
The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.
the FDA approved the first subcutaneous GLP-1 receptor agonist, exenatide (Byetta; Amylin Pharmaceuticals, Inc/Eli Lilly and Company), for the treatment of T2D. In the following years, more subcutaneous GLP-1 receptor agonists were approved for this indication, including liraglutide (Victoza; Novo...
Previously approved medications that have gained new FDA approval for the treatment of additional medical conditions.