Apitoria Pharma receives 5 observations from USFDA for API facility
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
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 study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users
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
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