The Food and Drug Administration (FDA) recently issued the following safety alerts.
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Our analysts scan more than 75 peer-reviewed journals and news briefings from government agencies, medical associations, and research institutes. Results of selected studies or articles are summarized and posted with a brief commentary on whether the findings are likely to have a substantial impact.
The Food and Drug Administration (FDA) is requiring new and updated warnings for Janus kinase (JAK) inhibitors Xeljanz/Xeljanz XR (tofacitinib; Pfizer), Olumiant (baricitinib; Eli Lilly and Co.), and Rinvoq (upadacitinib; AbbVie Inc).
The Food and Drug Administration (FDA) has announced a recall of the INGENIO pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps; Boston Scientific) due to the risk of incorrect transition to safety mode.
The Food and Drug Administration (FDA) issued a safety alert for Pepaxto (melphalan flufenamide; Oncopeptides AB) based on results from the OCEAN trial, which demonstrated an increased risk of death.
On July 16, the Food and Drug Administration (FDA) approved a new indication for Prograf (tacrolimus; Astellas Pharma US Inc.) based on observational study data providing real-world evidence (RWE) of effectiveness. It is the first drug approval based on RWE. The newly approved indication is for use in combination with other immunosuppressant drugs to prevent organ rejection i…
The Food and Drug Administration (FDA) issued a safety communication regarding potential mechanical failures and concerns about biocompatibility associated with components of the following NuVasive Specialized Orthopedics MAGEC devices:
On July 7, 2021, the Food and Drug Administration (FDA) posted a modified label for Aduhelm (aducanumab; Biogen Inc.) clarifying the population in which treatment should be initiated.
On June 30, 2021, the Food and Drug Administration (FDA) announced a recall of certain Philips Respironics ventilators, BiPAP, and CPAP machines due to potential health risks. These devices are used to provide breathing assistance.
On June 25, 2021, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Actemra (tocilizumab; Genentech Inc.) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal m…
Today the Food and Drug Administration (FDA) approved a biologics license application (BLA) for Aduhelm (aducanumab; Biogen) for the treatment of Alzheimer disease.