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Original New Drug Application Approvals by US FDA (01 - 15 April 2022)

18 Apr 2022

New drug applications approved by US FDA as of 01-15 April 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (01 - 15 April 2022)

18 Apr 2022

Obesity med cessation more likely after RYGB than sleeve gastrectomy

15 Apr 2022 by

Patients who are on obesity-related medications before undergoing bariatric surgery may be more likely to discontinue their medications and less likely to restart them after undergoing Roux-en-Y gastric bypass (RYGB) than laparoscopic sleeve gastrectomy (LSG), a recent study has shown.

Obesity med cessation more likely after RYGB than sleeve gastrectomy

15 Apr 2022

Vupanorsen lowers lipids in statin-treated individuals with high cholesterol levels

15 Apr 2022

In the management of statin-treated patients with elevated cholesterol levels, the antisense oligonucleotide targeting angiopoietin-like protein 3 (ANGPTL3) vupanorsen reduces levels of nonhigh-density lipoprotein cholesterol (non-HDL-C) and other lipid parameters, according to the results of TRANSLATE-TIMI 70.

Vupanorsen lowers lipids in statin-treated individuals with high cholesterol levels

15 Apr 2022

Add-on ixazomib yields survival gains in post-transplant myeloma

15 Apr 2022

The combination of lenalidomide plus ixazomib in the maintenance treatment of patients with post-transplant myeloma leads to better progression-free survival (PFS) compared with lenalidomide alone in historical controls, according to a study.

Add-on ixazomib yields survival gains in post-transplant myeloma

15 Apr 2022

Vupanorsen reduces non-HDL-C levels in adults with hyperlipidaemia already on statins

15 Apr 2022 by

Vupanorsen significantly reduces non–high-density lipoprotein cholesterol (non-HDL-C) levels in adults with hyperlipidaemia already taking statins, according to the TRANSLATE-TIMI 70* trial presented at ACC 2022.

Vupanorsen reduces non-HDL-C levels in adults with hyperlipidaemia already on statins

15 Apr 2022

Maintenance selinexor promising for PFS in advanced/recurrent endometrial cancer

14 Apr 2022 by

Maintenance treatment with selinexor improved progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer who had previously received first-line chemotherapy, particularly those with endometrioid histology and wild-type p53, according to a study presented at SGO 2022.

Maintenance selinexor promising for PFS in advanced/recurrent endometrial cancer

14 Apr 2022

Tamsulosin–mirabegron combo improves urination frequency but not voiding volume

14 Apr 2022

Treatment with the combination of tamsulosin plus mirabegron following 125I-brachytherapy for prostate cancer falls short of improving voiding volume compared with tamsulosin monotherapy, although the combination helps with urination frequency and overactive bladder symptoms, according to a study.

Tamsulosin–mirabegron combo improves urination frequency but not voiding volume

14 Apr 2022

Nivolumab-based regimen confers OS benefit, durable responses in advanced ESCC

14 Apr 2022 by

First-line treatment with nivolumab – be it in combination with chemotherapy (CT) or with ipilimumab – provided overall survival (OS) benefit and durable responses than CT alone in patients with advanced oesophageal squamous cell carcinoma (ESCC), according to findings from the phase III CheckMate 648 trial.

Nivolumab-based regimen confers OS benefit, durable responses in advanced ESCC

14 Apr 2022

Mix-and-match better than same-type booster vax against COVID-19

13 Apr 2022 by

Getting a heterologous vaccine booster appears to confer a greater protection against COVID-19 than homologous booster, suggest data from a Singapore study.

Mix-and-match better than same-type booster vax against COVID-19

13 Apr 2022

Chronic opioid use occurs in head and neck cancer patients on radiation therapy

13 Apr 2022

Patients with head and neck cancer who undergo radiation therapy tend to have persistent opioid use, reveals a study, noting further investigation on early intervention to appropriately wean patients.

Chronic opioid use occurs in head and neck cancer patients on radiation therapy

13 Apr 2022

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Original New Drug Application Approvals by US FDA (01 - 15 April 2022)

Original New Drug Application Approvals by US FDA (01 - 15 April 2022)

Obesity med cessation more likely after RYGB than sleeve gastrectomy

Obesity med cessation more likely after RYGB than sleeve gastrectomy

Vupanorsen lowers lipids in statin-treated individuals with high cholesterol levels

Vupanorsen lowers lipids in statin-treated individuals with high cholesterol levels

Add-on ixazomib yields survival gains in post-transplant myeloma

Add-on ixazomib yields survival gains in post-transplant myeloma

Vupanorsen reduces non-HDL-C levels in adults with hyperlipidaemia already on statins

Vupanorsen reduces non-HDL-C levels in adults with hyperlipidaemia already on statins

Maintenance selinexor promising for PFS in advanced/recurrent endometrial cancer

Maintenance selinexor promising for PFS in advanced/recurrent endometrial cancer

Tamsulosin–mirabegron combo improves urination frequency but not voiding volume

Tamsulosin–mirabegron combo improves urination frequency but not voiding volume

Nivolumab-based regimen confers OS benefit, durable responses in advanced ESCC

Nivolumab-based regimen confers OS benefit, durable responses in advanced ESCC

Mix-and-match better than same-type booster vax against COVID-19

Mix-and-match better than same-type booster vax against COVID-19

Chronic opioid use occurs in head and neck cancer patients on radiation therapy

Chronic opioid use occurs in head and neck cancer patients on radiation therapy