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
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
Dr. Reddy’s becomes the first pharmaceutical company to receive regulatory approval to launch Linaclotide in India under the brand name Colozo
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
Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension
The accelerated approval is supported by results from part 1 of the ESSENCE trial
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