News & Updates

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Lecanemab sustains benefit for AD in 3-year LEADER update

04 Sep 2026 by

Three years post-initial US FDA approval, lecanemab still shows ongoing clinical benefits and reduces amyloid plaques in patients with early Alzheimer’s disease (AD).

Lecanemab sustains benefit for AD in 3-year LEADER update

04 Sep 2026

GLP-1 RAs outperform SGLT2 inhibitors in mortality risk reduction in patients with serious mental illness

04 Sep 2026 by

In patients with serious mental illness (SMI), initiation of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) is associated with lower risks of all-cause mortality and major adverse cardiovascular events (MACEs) vs sodium-glucose cotransporter-2 (SGLT2) inhibitors, a large study has shown.

GLP-1 RAs outperform SGLT2 inhibitors in mortality risk reduction in patients with serious mental illness

04 Sep 2026

$Patients with refractory epilepsy report reduced seizures with cannabis-based products$

Patients with refractory epilepsy report reduced seizures with cannabis-based products

03 Sep 2026 by

The use of cannabis-based products for refractory epilepsy is associated with high perceived efficacy in a real-world public health setting in Brazil, with most patients reporting having their seizure frequency halved while experiencing mild-to-moderate adverse events (AEs).

Patients with refractory epilepsy report reduced seizures with cannabis-based products

03 Sep 2026

Bariatric surgery outdoes GLP-1 RAs for weight loss

03 Sep 2026

Patients with obesity achieve greater weight loss with bariatric surgery than glucagon-like peptide-1 receptor agonists (GLP-1 RAs) semaglutide and tirzepatide, a study has shown.

Bariatric surgery outdoes GLP-1 RAs for weight loss

03 Sep 2026

Veligrotug improves outcomes, life quality in patients with thyroid eye disease

03 Sep 2026 by

A five-infusion course of veligrotug, a full antagonist monoclonal antibody to the insulin-like growth factor-1 receptor (IGF-1R), over 12 weeks results in improved diplopia, proptosis, and disease activity and is well tolerated in patients with active thyroid eye disease (TED), as shown in the phase III THRIVE study. Moreover, the therapeutic effect persists through week 52.

Veligrotug improves outcomes, life quality in patients with thyroid eye disease

03 Sep 2026

Antimicrobial TDM detects toxic concentrations in paediatric setting

03 Sep 2026 by

Therapeutic drug monitoring (TDM) of antimicrobial agents in a paediatric setting succeeds in recognizing out-of-range serum drug concentrations (SDC), specifically for vancomycin and aminoglycosides, according to a single-centre study.

Antimicrobial TDM detects toxic concentrations in paediatric setting

03 Sep 2026

Lenacapavir continues to serve its PURPOSE in OLE study

03 Sep 2026 by

Twice-yearly subcutaneous lenacapavir continues to show high efficacy and is well tolerated among cisgender men and gender-diverse individuals in the open-label extension (OLE) of the PURPOSE 2 trial.

Lenacapavir continues to serve its PURPOSE in OLE study

03 Sep 2026

Mazdutide demonstrates weight-loss benefit in US cohort

03 Sep 2026

Once-weekly, subcutaneous mazdutide treatment yields meaningful reduction in bodyweight in a US cohort of adults with obesity or overweight, according to a phase II study.

Mazdutide demonstrates weight-loss benefit in US cohort

03 Sep 2026

Original New Drug Application Approvals by US FDA (1-15 December 2025)

03 Sep 2026

New drug applications approved by US FDA as of 1-15 December 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 (1-15 December 2025)

03 Sep 2026

Original New Drug Application Approvals by US FDA (1-15 August 2026)

03 Sep 2026

New drug applications approved by US FDA as of 1-15 August 2026 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 August 2026)

03 Sep 2026

News & Updates

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Lecanemab sustains benefit for AD in 3-year LEADER update

Lecanemab sustains benefit for AD in 3-year LEADER update

GLP-1 RAs outperform SGLT2 inhibitors in mortality risk reduction in patients with serious mental illness

GLP-1 RAs outperform SGLT2 inhibitors in mortality risk reduction in patients with serious mental illness

Patients with refractory epilepsy report reduced seizures with cannabis-based products

Patients with refractory epilepsy report reduced seizures with cannabis-based products

Bariatric surgery outdoes GLP-1 RAs for weight loss

Bariatric surgery outdoes GLP-1 RAs for weight loss

Veligrotug improves outcomes, life quality in patients with thyroid eye disease

Veligrotug improves outcomes, life quality in patients with thyroid eye disease

Antimicrobial TDM detects toxic concentrations in paediatric setting

Antimicrobial TDM detects toxic concentrations in paediatric setting

Lenacapavir continues to serve its PURPOSE in OLE study

Lenacapavir continues to serve its PURPOSE in OLE study

Mazdutide demonstrates weight-loss benefit in US cohort

Mazdutide demonstrates weight-loss benefit in US cohort

Original New Drug Application Approvals by US FDA (1-15 December 2025)

Original New Drug Application Approvals by US FDA (1-15 December 2025)

Original New Drug Application Approvals by US FDA (1-15 August 2026)

Original New Drug Application Approvals by US FDA (1-15 August 2026)