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Novartis Gene Therapies’ Libertyville, Ill., plant, which produces Zolgensma — the world’s most expensive drug at more than $2.1 million per treatment — has drawn a Form 483 with five observations during a June 8-16 inspection by the FDA. Read More
The FDA has approved Xeris Biopharma’s Recorlev (levoketoconazole) for treating hypercortisolemia in adults with Cushing’s syndrome who are unable to undergo surgery. Read More
CoronaVac, Sinovac’s COVID-19 vaccine, appears to be completely ineffective against the Omicron variant unless boosted with an mRNA vaccine, new data suggest. Read More
The approach taken by drugmakers during the pandemic turned out COVID-19 vaccines in record time, but it has some shortcomings for use in future drug development and manufacturing, according to a survey of more than 500 industry leaders. Read More
The Department of Justice alleged that the product was being marketed as a preventive or cure for coronavirus infection, making it an unapproved drug. Read More
Besides the FDA approval, tralokinumab has seen a stellar year, earning regulatory approvals in the EU, UK, Canada and the United Arab Emirates. Read More
A federal court has rejected Sanofi’s attempts to reinstate key patents covering a drug-device combination product dispensing its insulin blockbuster Lantus. Read More
A New York jury has found Teva Pharmaceuticals guilty of fueling the state’s opioid crisis through misleading marketing about the risks of its highly addictive painkillers. Read More