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The FDA announced that a memorandum of understanding (MOU) between the agency and states for regulating traditional compounding pharmacies that distribute their products to other states is now available for signature by state health agencies. Read More
The FDA has had to push back its review of Spectrum Pharmaceuticals’ biologics license application (BLA) for Rolontis (eflapegrastim) due to COVID-19 travel restrictions. Read More
The UK’s Institute of Cancer Research said it is “deeply disappointed” by a decision by the National Institute of Health and Care Excellence (NICE) to recommend Merck’s Keytruda (pembrolizumab) as a first-line treatment for certain head and neck cancer patients but not in combination with chemotherapy. Read More
Walmart is suing the federal government seeking to block civil charges against the company over how it handled prescriptions for opioids that allegedly helped create the opioid epidemic. Read More
The FDA says it won’t take action against wholesale distributors that fail to verify a product identifier or standardized numerical label before distributing saleable returned products. Read More
The COVID-19 pandemic is worsening a pre-existing problem of drug shortages in the U.S., University of Minnesota researchers report in a new analysis. Read More
HHS Secretary Alex Azar denies a report that he and colleagues are plotting the ouster of FDA Commissioner Stephen Hahn over Hahn’s holding fast to stricter, more time-consuming rules for makers of novel COVID-19 vaccines than what the White House wants. Read More
California Governor Gavin Newsom has named an 11-person scientific review panel to verify the safety of any FDA-approved COVID-19 vaccine before it is distributed in the state. Read More
Brazil’s President Jair Bolsonaro announced Wednesday that his government will not purchase a COVID-19 vaccine developed by Beijing-based Sinovac, just one day after the country’s health minister announced it would be placing an order. Read More