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The FDA issued a Form 483 with five observations to a Maryland-based sterile drug manufacturer, Pharmaceutics International, after an Oct. 19-30 inspection. Read More
Pfizer announced that its blockbuster rheumatoid arthritis drug Xeljanz (tofacitinib) failed to meet its primary endpoints in a postmarket safety study. Read More
The FDA called on drug compounders to know their active pharmaceutical ingredient (API) suppliers as it issued a warning letter to Houston, Texas-based Professional Compounding Centers of America (PCCA) for using a supplier whose drug ingredients had been placed on an import alert. Read More
The Government Accountability Office (GAO) has issued its fifth report on the federal government’s efforts to combat the COVID-19 pandemic, citing concerns that critical issues have still not been addressed, including the need for a “clear and comprehensive vaccine distribution plan.” Read More
Novartis CEO Vas Narasimhan said the company is looking to help other companies scale up production of COVID-19 vaccines and treatments and is currently in talks with “key players.” Read More
Novavax has announced interim results from a phase 3 UK trial that showed its COVID-19 vaccine candidate, NVX-CoV2373, demonstrated 89.3 percent efficacy but faltered in a separate study that evaluated the vaccine for the South Africa variant. Read More
More than two dozen patient and consumer advocacy groups are calling on the Biden administration to drop acting FDA Commissioner Janet Woodcock as a potential nominee for commissioner because of her role in the agency’s past handling of the nation’s opioid epidemic. Read More
Researchers from Pfizer and the University of Texas Medical Branch have found that the Pfizer/BioNTech COVID-19 vaccine was still able to effectively neutralize key mutations in the highly contagious UK and South African coronavirus strains, offering hope that the prominent vaccine won’t need to be readjusted at this point. Read More