MUMBAI, India, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Lords Mark Industries Ltd., has received US FDA registration for its range ...
Richter and Hikma have received the green light from the Food and Drug Administration for their biosimilar denosumab products, Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), referencing Prolia ...
Pharmaceutical Technology on MSN
FDA winds down operations amid government shutdown
Though the FDA will continue its core activities, the agency will no longer be accepting NDAs and BLAs until the ...
Detailed results from bezuclastinib’s positive SUMMIT trial evaluating bezuclastinib in patients with NonAdvanced Systemic ...
Infant Bacterial Therapeutics AB ( ($SE:IBT.B) ) has issued an update. Infant Bacterial Therapeutics is advancing the registration process for its ...
Sonoma Pharmaceuticals expands market reach with US FDA registration and Microcyn-based product listing under MoCRA: Boulder, Colorado Friday, October 10, 2025, 14:00 Hrs [IST] So ...
Breakthrough Therapy designation granted based on FDA’s review of available clinical evidence of safety and efficacy from all 12 patients treated ...
The FDA has outlined a new review process for drugs and biologics designed to treat ultrarare genetic diseases that would allow a single-arm trial, plus other supportive data, to serve as pivotal ...
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