SCH-39304 has entered Phase II trials for treatment of serious systemic fungal infections including Candida, cryptococcal meningitis, Aspergillus and Trichophyton - infections frequently occurring in cancer patients undergoing chemotherapy as well as AIDS patients. The product will likely compete in the U.S. market against Pfizer's Diflucan (fluconazole), for which an NDA is currently pending. SCH-39304 is licensed from the Japanese firm Sumitomo, which has retained marketing rights for Japan and certain Far East countries....
You may also be interested in...
Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker
Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.
Effective medical device regulation supports both safety and innovation needs. This article assesses how well the US FDA and the Australian TGA achieve this balance.