MPR

FDA Approves Eylea HD for RVO, Adds Monthly Dosing Option

The FDA also approved an every 4 week dosing regimen across all approved indications for patients who may not maintain a response on extended dosing intervals following successful initial treatment.
MPR

FDA Expands Koselugo for Adults With NF1 Plexiform Neurofibromas

The Food and Drug Administration (FDA) has approved Koselugo ® (selumetinib) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Previously, ...
MPR

FDA Grants Traditional Approval to Darzarlex Faspro for AL Amyloidosis

Darzalex Faspro ® is a subcutaneous formulation that combines daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase that increases permeability of the subcutaneous ...
MPR

Imdelltra Gains Traditional Approval for Extensive Stage Small Cell Lung Cancer

The Food and Drug Administration (FDA) has granted traditional approval to Imdelltra ® (tarlatamab-dlle) for the treatment of adults with extensive stage small cell lung cancer (ES-SCLC) with disease ...
MPR

Hyrnuo Granted Accelerated Approval for HER2-Mutant NSCLC

In patients naïve to HER2-targeted therapy, the objective response rate was 71% with a median duration of response of 9.2 months.
MPR

Countries Involved in US Clinical Trials Do Not Gain Timely Access to Approved Medicines

HealthDay News — Most countries involved in clinical trials for US Food and Drug Administration approvals do not gain timely physical access to the medicines that they help evaluate, according to a ...
MPR

Novo Nordisk Rolls Out Lower Prices for Ozempic and Wegovy

HealthDay News — People paying out of pocket for Ozempic or Wegovy may soon see lower costs, as Novo Nordisk rolls out new price discounts for its popular GLP-1 medications. The company announced that ...
MPR

FDA Approves Redemplo for Familial Chylomicronemia Syndrome

Plozasiran is an apoC-III-directed small interfering ribonucleic acid designed to reduce levels of hepatic and serum apoC-III ...
MPR

Mixed Results for Mitapivat in Sickle Cell Disease Trial

Agios Pharmaceuticals plans to share data from RISE UP with the Food and Drug Administration to support the approval of the sickle cell disease indication.
MPR

Risks for Vascular, Inflammatory Diseases Increased for Children After COVID-19

COVID-19 diagnosis linked to higher risk for arterial thromboembolism, venous thromboembolism, thrombocytopenia, myocarditis or pericarditis ...
MPR

Recommendations Developed for Managing Community-Acquired Pneumonia in Adults

Lung ultrasound is acceptable diagnostic alternative to chest radiography in medical centers with appropriate clinical expertise.
MPR

Doravirine/Islatravir Noninferior to BIC/FTC/TAF in Treatment-Naïve Adults With HIV-1

The investigational oral therapy combines doravirine, a non-nucleoside reverse transcriptase inhibitor, with islatravir, a nucleoside reverse transcriptase translocation inhibitor, in a single tablet ...