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Manufacturing

FDA rejects Alvotech's Humira copycat on manufacturing issues

The FDA rejected Alvotech’s application to approve its biosimilar copycat drug of AbbVie’s blockbuster immunology asset Humira after an inspection.
Joseph Keenan Sep 8, 2022 9:25am

FDA slaps Biocon following inspections of biosimilar production

Sep 1, 2022 9:35am

UCB’s anti-seizure drug suspended by Chinese regulators

Aug 24, 2022 9:55am

FDA pings Emergent's Camden site for 'contamination issues'

Aug 17, 2022 11:07am

FDA cracks down on Amazon for unapproved mole removal products

Aug 9, 2022 3:45pm

FDA hits Spanish drug substance maker Bioiberica with a Form 483

Jun 16, 2022 10:50am