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
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
WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission
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
Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing
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