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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
Last month, Commissioner Scott Gottlieb said the decline in approvals was temporary, attributing the slowdown to drugmakers’ implementation of the agency’s new impurity guidelines. Read More
The FDA’s approvals of generic drugs picked up slightly in February after January’s steep dropoff, while overall ANDA submissions dropped sharply, according to the agency’s latest monthly report. Read More
Most oncology treatments that received the FDA’s accelerated approval pathway in the past 25 years have demonstrated a clinical benefit, according to a review by agency officials published in the journal JAMA Oncology. Read More