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Spectrum Pharmaceutical’s experimental cancer drug Pozenveo (poziotinib) got the thumbs down from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in a vote of nine to four yesterday. Read More
Reauthorization of FDA’s user fee legislation moved ahead a step on Thursday as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee agreed to include a slimmed-down version of user fee legislation and smaller policy riders on a short-term government funding bill, or continuing resolution (CR). Read More
Following a month-long inspection in August, the FDA reprimanded Catalent for numerous quality lapses observed at its Bloomington, Ind., plant — where the drugmaker has performed manufacturing activities for both Moderna’s and Johnson & Johnson’s COVID-19 vaccines. Read More
In briefing documents, the FDA expressed four major concerns about Pozenveo (poziotinib), Spectrum Pharmaceutical’s experimental lung and breast cancer drug, ahead of today’s meeting of the FDA’s Oncologic Drugs Advisory Committee. Read More
Makers of generics and biosimilars who have a hard time obtaining the samples of the reference product they need to develop their alternative products can turn to the FDA for documentation to present to reluctant brand-name owners. Read More