Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older
Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices
Coveris’ security labels also work seamlessly with self-checkouts where around 80% of retail sales now typically occur
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
For the 2024 outlook, sales growth is now expected to be 22-28% at CER
The inspection was concluded with zero observations
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
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