FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
The new lineup includes CereTom Elite, OmniTom Elite, OmniTom Elite PCD, and BodyTom 32/64
New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
AiMeD noted that proposed GST changes—to either 5% or 18%—both present significant risks requiring carefully nuanced consideration
The first pillar is advanced manufacturing, focused on upgrading existing CDMO
Protein L is known as a “superantigen” because it can bind antibodies in unusual ways
Terufusion Advanced Infusion Systems combine a smart syringe pump, smart infusion pump, and pump monitoring system software for precise and efficient drug administration
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
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