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
Triggering global regulatory submissions this year for the treatment of obesity
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
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