The FDA amended the emergency use authorization (EUA) for both the Pfizer and Moderna COVID-19 vaccines to allow for an additional dose in certain immunocompromised individuals, specifically organ transplant recipients, or those who are diagnosed with conditions that are considered...
The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in patients weighing at least 40 kilograms (about 88 pounds) with COVID-19 who are at high risk for progression...
Hospira voluntarily recalled lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection and lot EG8933 of 1% Lidocaine HCl Injection, due to mislabeling whereby a portion of each lot was incorrectly labeled as the other product. Both drugs are indicated for the...
In April, the FDA and the CDC announced that six women experienced rare and severe blood clots after receiving the Johnson & Johnson COVID-19 vaccine. As of April 12, 2021, more than 6.8 million doses of this specific vaccine have...
An FDA safety review found the potential for increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine).These studies began when the FDA received reports of...
As of early March, three COVID-19 vaccines received emergency use authorization (EUAs) from the FDA. InDecember, the Pfizer/BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine received EUAs, and in lateFebruary the Johnson & Johnson/Janssen COVID-19 vaccine received an EUA. Both...
The FDA alerted clinical laboratory staff and healthcare providers that genetic variants of COVID-19 may lead to false negative results in certain diagnostic tests. This alert applies to all molecular COVID-19 tests, though the FDA continues to monitor the effect...
The FDA alerted the public that preliminary results from a safety clinical trial found an increased risk of serious heart related problems and cancer with Xeljanz (tofacitinib) and Xeljanz XR. These drugs are indicated for the treatment of rheumatoid arthritis,...
In November of 2020, the FDA issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody designed to block the coronavirus’ attachment and entry into human cells, for the treatment of mild-to-moderate COVID-19. However, in April of 2021,...
