First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects
Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
Also received tentative approval for 137 mg
MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
The inspection was concluded with zero observations
CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies Merck’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Pharmaceuticals and Consumer Health report higher sales (Fx & portfolio adj.) and lower earnings
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