The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season
Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Subscribe To Our Newsletter & Stay Updated
