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
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,
The first pillar is advanced manufacturing, focused on upgrading existing CDMO
Dr. Reddy’s becomes the first pharmaceutical company to receive regulatory approval to launch Linaclotide in India under the brand name Colozo
Merck will share two oral presentations on ASCVD treatment patterns and patient burden
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