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
Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort
NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity
According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million
The accelerated approval is supported by results from part 1 of the ESSENCE trial
Sarepta has also entered into an agreement with Arrowhead to transfer 2,660,989 shares of Arrowhead common stock in satisfaction of $50 million of the company’s previously announced $100 million milestone payment obligation
The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants
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