Drug Approval | August 28, 2025
Gilead’s Yeytuo approved in EU for HIV prevention
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
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
Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,
Merck will share two oral presentations on ASCVD treatment patterns and patient burden
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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