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Original New Drug Application Approvals by US FDA (16-30 June 2024)

15 Jul 2024

New drug applications approved by US FDA as of 16-30 June 2024 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 (16-30 June 2024)

15 Jul 2024

Ivonescimab plus chemo confers progression-free survival advantage in pretreated NSCLC

14 Jul 2024

Ivonescimab plus chemotherapy has a tolerable safety profile and appears to significantly prolong progression-free survival (PFS) in patients with nonsmall cell lung cancer (NSCLC) whose disease progressed while receiving EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy, according to interim data from the phase III HARMONi-A study.

Ivonescimab plus chemo confers progression-free survival advantage in pretreated NSCLC

14 Jul 2024

Tofacitinib improves response, lowers mortality in severe UC

13 Jul 2024 by

In patients with acute severe ulcerative colitis (UC), the addition of tofacitinib to corticosteroids results in better response to treatment, reveals a study. This benefit persists beyond 7 days, as shown by the lower rates of medical or surgical rescue therapy at 90 days.

Tofacitinib improves response, lowers mortality in severe UC

13 Jul 2024

Certain antipsychotics tied to increased pneumonia risk

13 Jul 2024

Specific antipsychotic drugs such as high-dose quetiapine, high- and medium-dose clozapine, and high-dose olanzapine appear to be associated with a heightened risk of pneumonia among patients with schizophrenia, as shown in a study.

Certain antipsychotics tied to increased pneumonia risk

13 Jul 2024

NATALEE update: Ribociclib + NSAI well tolerated

12 Jul 2024 by

Latest findings from the ongoing phase III NATALEE trial have shown that 3-year treatment with adjuvant ribociclib, in combination with a nonsteroidal aromatase inhibitor (NSAI), remained well tolerated in patients with HR+/HER2- early-stage breast cancer (EBC).

NATALEE update: Ribociclib + NSAI well tolerated

12 Jul 2024

Osimertinib extends PFS by 3.2 years in LAURA

12 Jul 2024 by

Osimertinib extends progression-free survival (PFS) sevenfold longer than placebo in patients with unresectable stage III EGFR-mutated non–small cell lung cancer (NSCLC) following definitive chemoradiotherapy, as shown in the primary analysis of the phase III LAURA study presented at ASCO 2024. This breakthrough makes osimertinib the first EGFR inhibitor to show benefit in a stage III setting.

Osimertinib extends PFS by 3.2 years in LAURA

12 Jul 2024

Real-world data support DOACs over warfarin for VTE

12 Jul 2024 by

The direct oral anticoagulants (DOACs) apixaban and rivaroxaban trump warfarin for the treatment of venous thromboembolism (VTE) in a retrospective observational analysis comprising real-world VTE patients from Finland, Norway, and Sweden.

Real-world data support DOACs over warfarin for VTE

12 Jul 2024

5:2 intermittent fasting plan makes a difference in early type 2 diabetes

11 Jul 2024 by

An intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake and meal replacement diet (5:2 MR) helps keep a lid on blood sugar and promote weight loss in adults with overweight or obesity and early type 2 diabetes (T2D), according to the results of the open-label EARLY* study from China.

5:2 intermittent fasting plan makes a difference in early type 2 diabetes

11 Jul 2024

Kidney, heart benefits FLOW with semaglutide

10 Jul 2024 by

Semaglutide reduces the risk of major kidney disease-related events and death from cardiovascular causes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), as shown in the FLOW* study presented at ERA 2024.

Kidney, heart benefits FLOW with semaglutide

10 Jul 2024

Alpha-blockers hold therapeutic potential against dementia with Lewy bodies

10 Jul 2024 by

The use of the alpha-1 adrenergic receptor antagonists (alpha-blockers) terazosin, doxazosin, and alfuzosin—medications for benign prostate hyperplasia (BPH)—may help reduce the incidence of dementia with Lewy bodies (DLB) in men, as suggested in a study.

Alpha-blockers hold therapeutic potential against dementia with Lewy bodies

10 Jul 2024

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Original New Drug Application Approvals by US FDA (16-30 June 2024)

Original New Drug Application Approvals by US FDA (16-30 June 2024)

Ivonescimab plus chemo confers progression-free survival advantage in pretreated NSCLC

Ivonescimab plus chemo confers progression-free survival advantage in pretreated NSCLC

Tofacitinib improves response, lowers mortality in severe UC

Tofacitinib improves response, lowers mortality in severe UC

Certain antipsychotics tied to increased pneumonia risk

Certain antipsychotics tied to increased pneumonia risk

NATALEE update: Ribociclib + NSAI well tolerated

NATALEE update: Ribociclib + NSAI well tolerated

Osimertinib extends PFS by 3.2 years in LAURA

Osimertinib extends PFS by 3.2 years in LAURA

Real-world data support DOACs over warfarin for VTE

Real-world data support DOACs over warfarin for VTE

5:2 intermittent fasting plan makes a difference in early type 2 diabetes

5:2 intermittent fasting plan makes a difference in early type 2 diabetes

Kidney, heart benefits FLOW with semaglutide

Kidney, heart benefits FLOW with semaglutide

Alpha-blockers hold therapeutic potential against dementia with Lewy bodies

Alpha-blockers hold therapeutic potential against dementia with Lewy bodies