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FibroGen admitted that it provided manipulated heart safety data to the FDA for its experimental oral anemia drug, roxadustat, throwing doubts over its potential approval as a treatment for anemia linked to chronic kidney disease (CKD). Read More
The FDA has moved to delay more reviews of oral Janus Kinase (JAK) inhibitors after recently pushing back its review timeframe for AbbVie’s Rinvoq (upadacitinib), postponing its decisions on separate submissions filed by Pfizer and Eli Lilly/Incyte by three months. Read More
The Rockville, Md., company also plans to submit a supplemental New Drug Application later this year, seeking approval for the drug for the treatment of adults. Read More
The FDA released Q&A guidance yesterday on bioequivalence (BE) studies for generic drugs and abbreviated new drug application (ANDA) submissions during the COVID-19 pandemic. Read More
Lenzilumab is meant to alleviate the symptoms of cytokine release syndrome, an immune system malfunction that can cause low oxygen levels in the lungs. Read More
Three members of an FDA advisory committee who reviewed Biogen’s investigational Alzheimer’s drug, aducanumab, have written an op-ed article in the Journal of the American Medical Association alleging an “unusual degree of collaboration” between the FDA and Biogen “potentially compromised the FDA’s objectivity” in conducting its review of the drug. Read More
The company said it has already shared the new findings with the FDA and plans to hold discussions with the agency aimed at lifting the clinical hold. Read More
CHMP said the drug’s benefits and risks remained positive and that including the data on the label would help doctors evaluate the drug when deciding to use. Read More
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