作者: 美国新药获批。 US FDA Novel Drug Approvals for 2024. 美国新药获批。🔗: 网页链接
Selected drug approvals anticipated in the 12-month period covering the fourth quarter of 2023 through the third quarter of 2024 are reviewed. The analysis emphasizes drugs selected from 58 novel drugs awaiting FDA approval that are expected to have significant clinical and financial impact in hospit...
Food and Drug Administration (FDA) and Ruxoprubart The FDA's clearance of the IND in Phase II trial brings us one step closer to treating several renal disorders, including IgAN. An additional Phase II trial is under regulatory review by the regulatory agency in a c...
Objective: To analyze the novel drugs approved by U.S. Food and Drug Administration(FDA) in 2016 so as to provide references for medicine field and related management departments. Methods: The information of the novel drugs approved by FDA was collected from the column of "Drug Innovation" and...
S. Food and Drug Administration( FDA) in 2017 so as to provide references for drug regulators and new drug researchers. Methods: The information of the novel drugs approved by FDA in 2017 and over the years was collected form FDA official website and was analyzed. Results Conclusion: FDA ...
FDA Issues Warning to Sanofi About API CGMP Deviations, Puts Clinical Hold on Atara Immunotherapies Patrick Lavery January 24th 2025 Article The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in Jun...
The recent approval of a multi-drug combination treatment program for cervical cancer and esophageal squamous cell carcinoma, along with the expansion of 9MW2821's indication to include the perioperative stage for urothelial carcinoma, is anticipated to significantly broaden the therapeutic reach of 9MW...
The recent approval of a multi-drug combination treatment program for cervical cancer and esophageal squamous cell carcinoma, along with the expansion of 9MW2821's indication to include the perioperative stage for urothelial carcinoma, is anticipated to significa...
Novel Insomnia Drug Receives FDA Approvaldoi:10.1016/S1541-9800(05)70741-9Saturday Evening PostSaturday Evening Post
GC Biopharma’s representative further emphasized, “With this IND approval, we can now enter phase 1 clinical and we will do our utmost in new drug development to provide hope to patients suffering from the disease.” About GC BiopharmaCorp. ...