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Original New Drug Application Approvals by US FDA (1-15 July 2024)

17 Jul 2024

New drug applications approved by US FDA as of 1-15 July 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 (1-15 July 2024)

17 Jul 2024

Automated insulin delivery system beneficial for T2D management

16 Jul 2024 by

An automated insulin delivery (AID) system appears to improve clinical outcomes in people with type 2 diabetes (T2D), with the pivotal SECURE-T2D trial showing substantial improvements in glycated haemoglobin, total daily insulin dose, and diabetes distress, without increasing the risk of hypoglycaemia.

Automated insulin delivery system beneficial for T2D management

16 Jul 2024

Breastfeeding may prevent development of JSpA in infants

16 Jul 2024

Infant factors affecting the microbiome appears to influence the occurrence of juvenile spondyloarthritis (JSpA), suggests a study, noting a link between exclusive breastfeeding and lower odds of JSpA.

Breastfeeding may prevent development of JSpA in infants

16 Jul 2024

Eating more fibre-rich foods, less red meat and sugar may prolong life expectancy

16 Jul 2024 by

Changing your usual eating pattern to one that is focused on longevity can bring substantial increases in life expectancy (LE), suggests a study that involved seven countries. These dietary changes include more whole grains, legumes, and nuts and less red/processed meats, sugars, and sugar-sweetened beverages.

Eating more fibre-rich foods, less red meat and sugar may prolong life expectancy

16 Jul 2024

Weight gain tied to hypertension in patients on methadone maintenance treatment

16 Jul 2024

The occurrence of hypertension in patients with opioid use disorder receiving methadone maintenance treatment (MMT) is associated with weight gain, reports a study.

Weight gain tied to hypertension in patients on methadone maintenance treatment

16 Jul 2024

Pemvidutide gains MOMENTUM in phase II obesity trial

16 Jul 2024 by

Pemvidutide, an investigational, peptide-based GLP-1/glucagon dual receptor agonist, gains traction in the booming obesity drug market, delivering significant weight loss reductions in nondiabetic individuals with overweight or obesity in the phase II MOMENTUM trial.

Pemvidutide gains MOMENTUM in phase II obesity trial

16 Jul 2024

Ph+ ALL: 1L ponatinib ups MRD-negative CR at end of induction vs imatinib

16 Jul 2024 by

Minimal residual disease (MRD)–negative complete remission (CR) rate at end of induction is significantly higher in adult patients with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukaemia (ALL) treated with ponatinib vs imatinib combined with reduced-intensity chemotherapy, results of the phase III PhALLCON trial have shown.

Ph+ ALL: 1L ponatinib ups MRD-negative CR at end of induction vs imatinib

16 Jul 2024

GLP-1RA treatment for T2DM may lower risk of surgery in inflammatory bowel disease

16 Jul 2024

Use of glucagon-like peptide-1 receptor agonist (GLP-1RA) appears to reduce the risk of inflammatory bowel disease (IBD)-related surgery in patients with type 2 diabetes mellitus (T2DM) and concomitant ulcerative colitis (UC) or Crohn’s disease (CD), according to a retrospective study.

GLP-1RA treatment for T2DM may lower risk of surgery in inflammatory bowel disease

16 Jul 2024

Tirzepatide reduces sleep apnoea severity in obese patients

16 Jul 2024 by

Treatment with tirzepatide significantly reduced sleep apnoea severity, as shown by a reduction in apnoea-hypopnea index (AHI), among patients with moderate-to-severe obstructive sleep apnoea (OSA) and obesity, regardless of positive airway pressure (PAP) therapy, according to two SURMOUNT-OSA trials presented at ADA 2024.

Tirzepatide reduces sleep apnoea severity in obese patients

16 Jul 2024

Phase II trial of nipocalimab for Sjögren’s disease turns in promising results

15 Jul 2024 by

The investigational monoclonal antibody nipocalimab helped reduce the intensity of Sjögren’s disease in adults in the phase II DAHLIAS trial.

Phase II trial of nipocalimab for Sjögren’s disease turns in promising results

15 Jul 2024

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Original New Drug Application Approvals by US FDA (1-15 July 2024)

Original New Drug Application Approvals by US FDA (1-15 July 2024)

Automated insulin delivery system beneficial for T2D management

Automated insulin delivery system beneficial for T2D management

Breastfeeding may prevent development of JSpA in infants

Breastfeeding may prevent development of JSpA in infants

Eating more fibre-rich foods, less red meat and sugar may prolong life expectancy

Eating more fibre-rich foods, less red meat and sugar may prolong life expectancy

Weight gain tied to hypertension in patients on methadone maintenance treatment

Weight gain tied to hypertension in patients on methadone maintenance treatment

Pemvidutide gains MOMENTUM in phase II obesity trial

Pemvidutide gains MOMENTUM in phase II obesity trial

Ph+ ALL: 1L ponatinib ups MRD-negative CR at end of induction vs imatinib

Ph+ ALL: 1L ponatinib ups MRD-negative CR at end of induction vs imatinib

GLP-1RA treatment for T2DM may lower risk of surgery in inflammatory bowel disease

GLP-1RA treatment for T2DM may lower risk of surgery in inflammatory bowel disease

Tirzepatide reduces sleep apnoea severity in obese patients

Tirzepatide reduces sleep apnoea severity in obese patients

Phase II trial of nipocalimab for Sjögren’s disease turns in promising results

Phase II trial of nipocalimab for Sjögren’s disease turns in promising results