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In a 17-0 vote, the FDA’s Antimicrobial Drugs Advisory Committee voted that the data show a favorable risk-benefit profile for TPOXX (tecovirimat) for its proposed indication for treating smallpox caused by variola virus in adults and pediatric patients. Read More
The CHMP also recommended approval of Carmustine Obvius (carmustine) a generic drug for treatment Hodgkin’s disease, non-Hodgkin’s lymphoma and brain tumors. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended three medicines for approval and eight extensions at its April 23-26 meeting. Read More
CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes. Read More
After experiencing a steep decline early in 2018, generic drug approvals by the FDA are climbing back towards last year’s highs according to the latest FDA report. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six medicines, including an orphan drug, for approval at its March meeting, in addition to three recommendations for extensions of indications. Read More