Drug Approval | August 31, 2025
FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
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
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB
Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control
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