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The FDA hit Salisbury, Maryland generic drug manufacturer Jubilant Cadista Pharmaceuticals for failing to control the risk of product contamination and for submitting late field alert reports, among other violations. Read More
Fewer than a third of new drugs approved by the FDA and the European Medicines Agency over the past decade had high therapeutic value, a team of U.S. and Swiss researchers found. Read More
The first participant has been dosed in Vaxart’s phase 1 study of an oral COVID-19 vaccine tablet the company is developing as an alternative to injectable vaccines. If approved, it would be the first-ever vaccine in tablet form. Read More
A clinical trial of Eli Lilly’s antibody candidate treatment for COVID-19 was paused Tuesday following a safety incident — awkward timing as the company has just applied to the FDA for an Emergency Use Authorization (EUA) for the product. Read More
After inspecting its facility in Chatsworth, Calif., the FDA rapped Thibiant International for inadequate good manufacturing practices, complaint handling and training. Read More
Avenue Therapeutics has a received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for intravenous tramadol, meant for treating acute pain in adults. Read More
The British Embassy in Bangkok announced Monday that Thailand will pitch in to manufacture AstraZeneca’s COVID-19 vaccine candidate to bolster the supply in southeast Asia. Read More
Eli Lilly says its rheumatoid arthritis (RA) therapy Olumiant (baricitinib) combined with Gilead Sciences’ antiviral remdesivir reduced COVID-19 patient recovery time by 12.5 percent, or from eight to seven days, over remdesivir alone. Read More
Mallinckrodt filed for bankruptcy protection Monday as the company faces billions of dollars in legal liabilities over its role in the nation’s opioid epidemic. Read More