FDA News

Three falsified batches of semaglutide (Ozempic) are in circulation, posing risks for ineffective treatment due to incorrect dosing, contamination, and use of unknown ingredients, warned WHO.

Among youth aged 10 to 17 years with uncontrolled hyperglycemia dapagliflozin led to a statistically significant reduction in A1c vs placebo in the T2NOW phase 3 clinical trial.

Capvaxive is the only pneumococcal vaccine formulated specifically to protect adults 50 years and older from IPD and elicited robust immune responses in both vaccine-naïve and vaccine-experienced adults.

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The investigational combination vaccine elicited higher immune responses vs licensed comparator vaccines in 2 independent age groups, the company said.

Abbott becomes the second company to receive FDA clearance for an over-the-counter continuous glucose monitoring system.

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The over-the-counter antigen test, for use at home or at point of care, discriminates between SARS-CoV-2 and influenza A and B in 15 minutes.

mRESVIA is Moderna's second mRNA-based vaccine and will be shipped in prefilled syringes, a desirable feature that could save clinical time, prevent errors.

FDA has no concerns about the "approvability" of dupilumab for the new indication but needs additional time to review phase 3 data it requested early in May.