Nda apply date 2023

The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application (NDA) seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors. 1 The regulatory agency granted priority review to the NDA in February 2023 and had set an action date of August 27, 2023. 2 The application was supported by findings from the phase 3 DeFi trial (NCT03785964), in which the agent reduced the risk of disease progression or death by 71% compared with placebo in this population (HR, 0.29; 95% CI, 0.15-0.55; P < .001). 3 The Kaplan-Meier–estimated median progression-free survival (PFS) could not be estimated with nirogacestat (n = 70) because of a low number of events; however, the median PFS with placebo (n = 72) was 15.1 months (95% CI, 8.4-not estimable). The likelihood of being event free at 1 year was higher in the nirogacestat arm vs the placebo arm, at 85% (95% CI, 73%-92%) and 53% (95% CI, 40%-64%), respectively. The rates for being event free at 2 years were 76% (95% CI, 61%-87%) and 44% (95% CI, 32%-56%). On June 2, 2023, the FDA notified SpringWorks Therapeutics, Inc., the drug developer, that more time was needed to assess the additional analyses of the previously submitted data that had been provided to the agency in response to initial information requests. Because the additional information provided was determined to represent a major amendment to the application, ...

NDA (2) 2023 application form will release on 17 May 2023. National Defence Academy is an entrance exam organized at the national level for the candidates who wish to be a part of Indian Navy, Air Force and Army. NDA is organized twice a year i.e. NDA(1) April session and NDA(2) November session by Union Public Service Commission (UPSC). The candidates are firstly supposed to clear the written test by scoring the minimum cut off marks. After which they can appear for 5- Days Service Selection Board (SSB) Interview round and hence get admission into National Defence Academy and Naval Academy. The candidates after qualifying the interview round of SSB have to go through the medical examination and document verification procedure. Latest Updates • NDA (2) will held after NDA (1). • NDA 2 application form will release in 17 May 2023. NDA (2) 2023 Exam Status Candidates can check the NDA (2) 2023 exam status from the below table: Particulars Status National Defence Academy and Naval Academy Examination 2 2023 Status Application form will release in May 2023 NDA (2) Important Dates 2023 Candidates can take note of all the important dates for NDA (2) 2023 from the table below. Events NDA II Dates Release of Notification 17 May 2023 Availability of Application Form 17 May 2023 Last date to apply 6 June 2023 Availability of Admit card Yet to announce NDA 2023 Exam 3 September 2023 Declaration of Result Yet to announce Interview Schedule To be notified soon NDA (2) 2023 Result NDA (...

NDA (2) 2023 application form will release on 17 May 2023. National Defence Academy is an entrance exam organized at the national level for the candidates who wish to be a part of Indian Navy, Air Force and Army. NDA is organized twice a year i.e. NDA(1) April session and NDA(2) November session by Union Public Service Commission (UPSC). The candidates are firstly supposed to clear the written test by scoring the minimum cut off marks. After which they can appear for 5- Days Service Selection Board (SSB) Interview round and hence get admission into National Defence Academy and Naval Academy. The candidates after qualifying the interview round of SSB have to go through the medical examination and document verification procedure. Latest Updates • NDA (2) will held after NDA (1). • NDA 2 application form will release in 17 May 2023. NDA (2) 2023 Exam Status Candidates can check the NDA (2) 2023 exam status from the below table: Particulars Status National Defence Academy and Naval Academy Examination 2 2023 Status Application form will release in May 2023 NDA (2) Important Dates 2023 Candidates can take note of all the important dates for NDA (2) 2023 from the table below. Events NDA II Dates Release of Notification 17 May 2023 Availability of Application Form 17 May 2023 Last date to apply 6 June 2023 Availability of Admit card Yet to announce NDA 2023 Exam 3 September 2023 Declaration of Result Yet to announce Interview Schedule To be notified soon NDA (2) 2023 Result NDA (...

The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application (NDA) seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors. 1 The regulatory agency granted priority review to the NDA in February 2023 and had set an action date of August 27, 2023. 2 The application was supported by findings from the phase 3 DeFi trial (NCT03785964), in which the agent reduced the risk of disease progression or death by 71% compared with placebo in this population (HR, 0.29; 95% CI, 0.15-0.55; P < .001). 3 The Kaplan-Meier–estimated median progression-free survival (PFS) could not be estimated with nirogacestat (n = 70) because of a low number of events; however, the median PFS with placebo (n = 72) was 15.1 months (95% CI, 8.4-not estimable). The likelihood of being event free at 1 year was higher in the nirogacestat arm vs the placebo arm, at 85% (95% CI, 73%-92%) and 53% (95% CI, 40%-64%), respectively. The rates for being event free at 2 years were 76% (95% CI, 61%-87%) and 44% (95% CI, 32%-56%). On June 2, 2023, the FDA notified SpringWorks Therapeutics, Inc., the drug developer, that more time was needed to assess the additional analyses of the previously submitted data that had been provided to the agency in response to initial information requests. Because the additional information provided was determined to represent a major amendment to the application, ...

NDA (2) 2023 application form will release on 17 May 2023. National Defence Academy is an entrance exam organized at the national level for the candidates who wish to be a part of Indian Navy, Air Force and Army. NDA is organized twice a year i.e. NDA(1) April session and NDA(2) November session by Union Public Service Commission (UPSC). The candidates are firstly supposed to clear the written test by scoring the minimum cut off marks. After which they can appear for 5- Days Service Selection Board (SSB) Interview round and hence get admission into National Defence Academy and Naval Academy. The candidates after qualifying the interview round of SSB have to go through the medical examination and document verification procedure. Latest Updates • NDA (2) will held after NDA (1). • NDA 2 application form will release in 17 May 2023. NDA (2) 2023 Exam Status Candidates can check the NDA (2) 2023 exam status from the below table: Particulars Status National Defence Academy and Naval Academy Examination 2 2023 Status Application form will release in May 2023 NDA (2) Important Dates 2023 Candidates can take note of all the important dates for NDA (2) 2023 from the table below. Events NDA II Dates Release of Notification 17 May 2023 Availability of Application Form 17 May 2023 Last date to apply 6 June 2023 Availability of Admit card Yet to announce NDA 2023 Exam 3 September 2023 Declaration of Result Yet to announce Interview Schedule To be notified soon NDA (2) 2023 Result NDA (...

The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application (NDA) seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors. 1 The regulatory agency granted priority review to the NDA in February 2023 and had set an action date of August 27, 2023. 2 The application was supported by findings from the phase 3 DeFi trial (NCT03785964), in which the agent reduced the risk of disease progression or death by 71% compared with placebo in this population (HR, 0.29; 95% CI, 0.15-0.55; P < .001). 3 The Kaplan-Meier–estimated median progression-free survival (PFS) could not be estimated with nirogacestat (n = 70) because of a low number of events; however, the median PFS with placebo (n = 72) was 15.1 months (95% CI, 8.4-not estimable). The likelihood of being event free at 1 year was higher in the nirogacestat arm vs the placebo arm, at 85% (95% CI, 73%-92%) and 53% (95% CI, 40%-64%), respectively. The rates for being event free at 2 years were 76% (95% CI, 61%-87%) and 44% (95% CI, 32%-56%). On June 2, 2023, the FDA notified SpringWorks Therapeutics, Inc., the drug developer, that more time was needed to assess the additional analyses of the previously submitted data that had been provided to the agency in response to initial information requests. Because the additional information provided was determined to represent a major amendment to the application, ...

NDA (2) 2023 application form will release on 17 May 2023. National Defence Academy is an entrance exam organized at the national level for the candidates who wish to be a part of Indian Navy, Air Force and Army. NDA is organized twice a year i.e. NDA(1) April session and NDA(2) November session by Union Public Service Commission (UPSC). The candidates are firstly supposed to clear the written test by scoring the minimum cut off marks. After which they can appear for 5- Days Service Selection Board (SSB) Interview round and hence get admission into National Defence Academy and Naval Academy. The candidates after qualifying the interview round of SSB have to go through the medical examination and document verification procedure. Latest Updates • NDA (2) will held after NDA (1). • NDA 2 application form will release in 17 May 2023. NDA (2) 2023 Exam Status Candidates can check the NDA (2) 2023 exam status from the below table: Particulars Status National Defence Academy and Naval Academy Examination 2 2023 Status Application form will release in May 2023 NDA (2) Important Dates 2023 Candidates can take note of all the important dates for NDA (2) 2023 from the table below. Events NDA II Dates Release of Notification 17 May 2023 Availability of Application Form 17 May 2023 Last date to apply 6 June 2023 Availability of Admit card Yet to announce NDA 2023 Exam 3 September 2023 Declaration of Result Yet to announce Interview Schedule To be notified soon NDA (2) 2023 Result NDA (...

The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application (NDA) seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors. 1 The regulatory agency granted priority review to the NDA in February 2023 and had set an action date of August 27, 2023. 2 The application was supported by findings from the phase 3 DeFi trial (NCT03785964), in which the agent reduced the risk of disease progression or death by 71% compared with placebo in this population (HR, 0.29; 95% CI, 0.15-0.55; P < .001). 3 The Kaplan-Meier–estimated median progression-free survival (PFS) could not be estimated with nirogacestat (n = 70) because of a low number of events; however, the median PFS with placebo (n = 72) was 15.1 months (95% CI, 8.4-not estimable). The likelihood of being event free at 1 year was higher in the nirogacestat arm vs the placebo arm, at 85% (95% CI, 73%-92%) and 53% (95% CI, 40%-64%), respectively. The rates for being event free at 2 years were 76% (95% CI, 61%-87%) and 44% (95% CI, 32%-56%). On June 2, 2023, the FDA notified SpringWorks Therapeutics, Inc., the drug developer, that more time was needed to assess the additional analyses of the previously submitted data that had been provided to the agency in response to initial information requests. Because the additional information provided was determined to represent a major amendment to the application, ...

The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application (NDA) seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors. 1 The regulatory agency granted priority review to the NDA in February 2023 and had set an action date of August 27, 2023. 2 The application was supported by findings from the phase 3 DeFi trial (NCT03785964), in which the agent reduced the risk of disease progression or death by 71% compared with placebo in this population (HR, 0.29; 95% CI, 0.15-0.55; P < .001). 3 The Kaplan-Meier–estimated median progression-free survival (PFS) could not be estimated with nirogacestat (n = 70) because of a low number of events; however, the median PFS with placebo (n = 72) was 15.1 months (95% CI, 8.4-not estimable). The likelihood of being event free at 1 year was higher in the nirogacestat arm vs the placebo arm, at 85% (95% CI, 73%-92%) and 53% (95% CI, 40%-64%), respectively. The rates for being event free at 2 years were 76% (95% CI, 61%-87%) and 44% (95% CI, 32%-56%). On June 2, 2023, the FDA notified SpringWorks Therapeutics, Inc., the drug developer, that more time was needed to assess the additional analyses of the previously submitted data that had been provided to the agency in response to initial information requests. Because the additional information provided was determined to represent a major amendment to the application, ...

NDA (2) 2023 application form will release on 17 May 2023. National Defence Academy is an entrance exam organized at the national level for the candidates who wish to be a part of Indian Navy, Air Force and Army. NDA is organized twice a year i.e. NDA(1) April session and NDA(2) November session by Union Public Service Commission (UPSC). The candidates are firstly supposed to clear the written test by scoring the minimum cut off marks. After which they can appear for 5- Days Service Selection Board (SSB) Interview round and hence get admission into National Defence Academy and Naval Academy. The candidates after qualifying the interview round of SSB have to go through the medical examination and document verification procedure. Latest Updates • NDA (2) will held after NDA (1). • NDA 2 application form will release in 17 May 2023. NDA (2) 2023 Exam Status Candidates can check the NDA (2) 2023 exam status from the below table: Particulars Status National Defence Academy and Naval Academy Examination 2 2023 Status Application form will release in May 2023 NDA (2) Important Dates 2023 Candidates can take note of all the important dates for NDA (2) 2023 from the table below. Events NDA II Dates Release of Notification 17 May 2023 Availability of Application Form 17 May 2023 Last date to apply 6 June 2023 Availability of Admit card Yet to announce NDA 2023 Exam 3 September 2023 Declaration of Result Yet to announce Interview Schedule To be notified soon NDA (2) 2023 Result NDA (...