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Specialty drug manufacturer Acella Pharmaceuticals is recalling dozens of lots of NP Thyroid tablets, a drug for treatment of hypothyroidism, after it was determined that the products did not meet potency standards, a recurring issue for the company that previously prompted FDA enforcement action. Read More
The FDA sent a warning letter to Union City, Calif.-based drugmaker RPK Pharmaceuticals for mislabeling of a topical drug, saying the label for the drug did not match the description of the listed drug. Read More
The FDA has withdrawn five generic opioids from the U.S. market, after three sponsors failed to meet regulatory requirements for their abbreviated New Drug Applications (ANDAs). Read More
In more bad news for AstraZeneca, the European Medicines Agency (EMA) announced that its safety committee is investigating reports of capillary leak syndrome, a rare, potentially life-threatening disorder, in individuals inoculated with the company’s COVID-19 vaccine. Read More
The European Medicines Agency (EMA) announced yesterday that AstraZeneca should include the risk of very rare blood clots on the list of possible side effects of its COVID-19 vaccine — and a UK vaccines advisory committee said it would be “preferable” not to give the vaccine to individuals under age 30. Read More
The European Medicines Agency (EMA) confirmed yesterday that it has not found any causal link between blood clots and inoculation with the AstraZeneca (AZ) COVID-19 vaccine. Read More
The goal of the archive is to increase transparency about what led to the epidemic and “to ensure a similar crisis doesn’t occur again,” the universities said. Read More