News &amp; Updates

New drug applications approved by US FDA as of 16-31 May 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 (16-31 May 2024)

Olezarsen benefits hypertriglyceridemia patients at high cardiovascular risk

Treatment with olezarsen in patients with hypertriglyceridemia and elevated cardiovascular risk results in substantial reductions in triglyceride, apolipoprotein B, and non–high-density lipoprotein cholesterol levels, while having no major safety signals, according to data from the phase IIb Bridge–TIMI 73a study.

Olezarsen benefits hypertriglyceridemia patients at high cardiovascular risk

Benefits of investigational IgA nephropathy drug persist for 72 weeks

09 Jun 2024 by

Patients with IgA nephropathy (IgAN) who have been treated with atacicept continue to show improvement in disease status through 72 weeks, with consistent reductions in the key indicators of IgAN and the kidney function remaining stable, according to the open-label extension phase of the phase IIb ORIGIN study.

Benefits of investigational IgA nephropathy drug persist for 72 weeks

Chemo plus immunotherapy improves survival in advanced endometrial cancer

Adding immunotherapy to the first-line treatment for advanced and metastatic endometrial cancer may significantly improve some oncologic outcomes, particularly within the mismatch repair deficiency/microsatellite instability-hypermutated (MMRd/MSI-H) subset, suggests a study.

Chemo plus immunotherapy improves survival in advanced endometrial cancer

09 Jun 2024

CXCL13 in cerebrospinal fluid aids in neurosyphilis diagnosis

Evaluation of CXCL13 concentration in cerebrospinal fluid (CSF) shows good diagnostic accuracy for neurosyphilis, according to the results of a systematic review and meta-analysis.

CXCL13 in cerebrospinal fluid aids in neurosyphilis diagnosis

$Bispecific antibody delivers positive results in relapsed, refractory multiple myeloma$

Bispecific antibody delivers positive results in relapsed, refractory multiple myeloma

08 Jun 2024 by

A large percentage of patients with relapsed/refractory multiple myeloma (RRMM) respond to the bispecific antibody linvoseltamab, with deep and durable responses seen even in the high-risk subgroups, according to data from the phase I/II LINKER-MM1 trial.

Bispecific antibody delivers positive results in relapsed, refractory multiple myeloma

08 Jun 2024

Renal impairment, race affect maintenance warfarin dosing in Asian patients

08 Jun 2024 by

Race and renal function both influence maintenance warfarin dosing in a multi-ethnic Southeast Asian population, suggests a study in Singapore. Specifically, impaired renal function is associated with lower warfarin maintenance doses, while South Asians may require a larger dose than Chinese and Malays.

Renal impairment, race affect maintenance warfarin dosing in Asian patients

Lidocaine-filled dilators may minimize pain during IUD removal

Infusing lidocaine into a disposable injectable cervical dilator helps reduce pain during the removal of an intrauterine device (IUD), especially when intrauterine manipulations are needed, according to a study.

Lidocaine-filled dilators may minimize pain during IUD removal

Gastric fundus ablation targets hunger hormone for weight loss

08 Jun 2024 by

Ablating the gastric fundus to reduce the production of the hunger hormone ghrelin helps women curb their appetite and lose body weight in the ABLATE-WEIGHT first-in-human trial.

Gastric fundus ablation targets hunger hormone for weight loss