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The Indian government and the Russian Direct Investment Fund reached an agreement that will allow Indian companies to produce 850 million doses of the vaccine per year. Read More
The agency said it does not believe that the drug’s pharmacokinetic profile is comparable to the manufactured drug used by Eli Lilly when it was researching it more than a decade ago. Read More
The FDA granted the approval based on progression-free survival and overall survival rates from studies of cancer patients and real-world data. Read More
The FDA has approved a new, biweekly dosing regimen for ImClone’s cancer drug, Erbitux (cetuximab), for patients with a certain form of EGFR-expressing colorectal cancer or head and neck squamous-cell carcinoma. Read More
The FDA has granted full approval for Immunomedics’ Trodelvy (sacituzumab govitecan-hziy) for treating women with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior lines of therapy. Read More
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