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The House Energy and Commerce Committee passed by a voice vote Wednesday a measure that would ensure tropical disease priority review vouchers are not issued to products with regulatory approval in other countries. Read More
The time and effort to collect the quality metrics dictated in the FDA’s draft guidance are about three times higher than the FDA’s original estimates. Read More
In stark contrast to comments from generic industry trade groups, a patient advocacy organization is calling for including more information in biosimilar product labeling. Read More
Two FDA advisory committees backed the approval of Pfizer’s opioid Troxyca for severe pain management when alternative treatments are inadequate with abuse-deterrent labeling for nasal and intravenous routes. Read More
Biopharmaceutical firm Biocad has filed suit against Roche and its Genentech subsidiary over their alleged use of predatory pricing practices in Russia intended to decimate the sales of the Russian drugmaker’s biosimilars. Read More