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Original New Drug Application Approvals by US FDA (16-31 January 2025)

04 Feb 2025

New drug applications approved by US FDA as of 16-31 January 2025 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 (16-31 January 2025)

04 Feb 2025

MTX plus MMI for Graves’ disease tied to higher discontinuation rate

03 Feb 2025

The addition of low-dose methotrexate (MTX) to methimazole (MMI) shows a higher rate of discontinuation than MMI alone, as well as significant reductions in thyrotropin-related antibodies (TRAb) levels, in patients with Graves’ disease (GD), reveals a study.

MTX plus MMI for Graves’ disease tied to higher discontinuation rate

03 Feb 2025

Abnormal body weight in adolescence a risk factor for infertility in Asian women

02 Feb 2025

Underweight or obesity during adolescence may contribute to unexplained infertility later in life, as suggested in a large study involving Japanese women.

Abnormal body weight in adolescence a risk factor for infertility in Asian women

02 Feb 2025

Study supports continued metformin use in T2D patients with advanced kidney disease

31 Jan 2025

For patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), continued use of metformin for at least 6 months when eGFR falls below 30 mL/min/1.73m2 appears to yield a small but significant decrease in all-cause mortality, according to a nationwide observational cohort study.

Study supports continued metformin use in T2D patients with advanced kidney disease

31 Jan 2025

Determinants of semaglutide initiation in obesity

30 Jan 2025

In people with obesity but without diabetes, starting semaglutide treatment appears to be influenced by sociodemographic, health care, and clinical factors, according to a retrospective observational cohort study.

Determinants of semaglutide initiation in obesity

30 Jan 2025

Empagliflozin, dapagliflozin in a draw for renoprotection in T2D

29 Jan 2025 by

Long-term kidney outcomes in type 2 diabetes (T2D) are similar between empagliflozin- and dapagliflozin-treated patients, aligning with current clinical practice guidelines that do not favour one SGLT2 inhibitor over the other, according to a study.

Empagliflozin, dapagliflozin in a draw for renoprotection in T2D

29 Jan 2025

GLP-1 RAs reduce BP in overweight, obese patients

29 Jan 2025

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RA) significantly lowers blood pressure (BP) in obese or overweight patients, according to a study. This beneficial effect persists across diabetic status, duration of treatment, and route of administration.

GLP-1 RAs reduce BP in overweight, obese patients

29 Jan 2025

One basal insulin noninferior to another in type 2 diabetes

29 Jan 2025

In the management of type 2 diabetes (T2D) in adults who are naïve to insulin, once-weekly efsitora alfa compares favourably with once-daily degludec in terms of lowering glycated haemoglobin levels, according to an open-label phase III study.

One basal insulin noninferior to another in type 2 diabetes

29 Jan 2025

Novel injectable paste-based treatment promotes diabetic foot wound closure

27 Jan 2025 by

Micronized injectable human-derived acellular dermal matrices (ADM) may improve the healing of diabetic foot wounds, according to real-world data from Singapore.

Novel injectable paste-based treatment promotes diabetic foot wound closure

27 Jan 2025

Sit less, move more, as CV risk remains even with exercise

27 Jan 2025 by

For individuals who sit for the most part of their day, engaging in light or moderate physical activity may be insufficient to cancel out the cardiovascular (CV) risks tied to a sedentary lifestyle, a study suggests.

Sit less, move more, as CV risk remains even with exercise

27 Jan 2025

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Original New Drug Application Approvals by US FDA (16-31 January 2025)

Original New Drug Application Approvals by US FDA (16-31 January 2025)

MTX plus MMI for Graves’ disease tied to higher discontinuation rate

MTX plus MMI for Graves’ disease tied to higher discontinuation rate

Abnormal body weight in adolescence a risk factor for infertility in Asian women

Abnormal body weight in adolescence a risk factor for infertility in Asian women

Study supports continued metformin use in T2D patients with advanced kidney disease

Study supports continued metformin use in T2D patients with advanced kidney disease

Determinants of semaglutide initiation in obesity

Determinants of semaglutide initiation in obesity

Empagliflozin, dapagliflozin in a draw for renoprotection in T2D

Empagliflozin, dapagliflozin in a draw for renoprotection in T2D

GLP-1 RAs reduce BP in overweight, obese patients

GLP-1 RAs reduce BP in overweight, obese patients

One basal insulin noninferior to another in type 2 diabetes

One basal insulin noninferior to another in type 2 diabetes

Novel injectable paste-based treatment promotes diabetic foot wound closure

Novel injectable paste-based treatment promotes diabetic foot wound closure

Sit less, move more, as CV risk remains even with exercise

Sit less, move more, as CV risk remains even with exercise