A US Food and Drug Administration advisory committee gave a unanimous thumbs up to two new gene therapies: betibeglogene autotemcel (beti-cel) for the treatment of a […]
The US Food and Drug Administration (FDA) has approved brolucizumab (Beovu) for treatment of diabetic macular edema (DME), but included a warning about retinal vasculitis and […]
The US Food and Drug Administration (FDA) has announced a Class I recall for Philips Respironics V60 and V60 Plus ventilators, citing a power failure leading […]
The US Food and Drug Administration (FDA) has approved adding adult patients with rheumatoid arthritis (RA) to the list of indications for the rituximab biosimilar Riabni […]
The US Food and Drug Administration (FDA) published a warning from the medical device company Baxter International Inc, citing problems with their device used for at-home […]
The US Food and Drug Administration (FDA) has issued an update on the safety of the Renuvion Dermal Handpiece for dermal resurfacing, which has been cleared […]
Today, the US Food and Drug Administration (FDA) announced it has withdrawn approval of the lymphoma drug umbralisib (Ukoniq) following an investigation into a “possible increased […]
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