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
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
This project shall be implemented through incorporation of a new joint venture company in Zambia
Skyhawk Therapeutics enters into an option agreement to grant Merck KGaA, Darmstadt, Germany, exclusive global rights to drug candidates pursued under the collaboration upon option exercise
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
OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors
The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations
Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025
Phase 1 dosing is expected to finish by the end of 2025
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