fbpx
June 10, 2022

FDA Alert: Don’t Use OTC Products to Remove Skin Spots, Moles FDA Alert: Don’t Use OTC Products to Remove Skin Spots, Moles

Dr Adam Friedman Those moles, skin tags, and liver spots should stay on your skin until you see a doctor, according to a new alert from […]
June 8, 2022

FDA Approves Brolucizumab for Diabetic Macular Edema FDA Approves Brolucizumab for Diabetic Macular Edema

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 […]
June 8, 2022

FDA: Urgent Device Correction, Recall for Philips Ventilator FDA: Urgent Device Correction, Recall for Philips Ventilator

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 […]
June 7, 2022

FDA Adds RA Indication for Riabni Rituximab Biosimilar FDA Adds RA Indication for Riabni Rituximab Biosimilar

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 […]
June 7, 2022

FDA Warning Released for Volara Respiratory System FDA Warning Released for Volara Respiratory System

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 […]
June 2, 2022

FDA Issues Safety Update on Device Used for Aesthetic Procedures FDA Issues Safety Update on Device Used for Aesthetic Procedures

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 […]
June 1, 2022

FDA Withdraws Lymphoma Drug Approval After Investigation FDA Withdraws Lymphoma Drug Approval After Investigation

Today, the US Food and Drug Administration (FDA) announced it has withdrawn approval of the lymphoma drug umbralisib (Ukoniq) following an investigation into a “possible increased […]
May 31, 2022

FDA Clears Abbott Freestyle Libre 3 Glucose Sensor FDA Clears Abbott Freestyle Libre 3 Glucose Sensor

The US Food and Drug Administration has cleared Abbot’s Freestyle Libre 3 system for use by people with diabetes aged 4 years and older. The new […]
May 31, 2022

FDA Expands Indication for Spinal Muscular Atrophy Drug FDA Expands Indication for Spinal Muscular Atrophy Drug

The US Food and Drug Administration (FDA) has approved a label extension for oral risdiplam (Evrysdi, Genentech) to include presymptomatic infants  younger than 2 months old […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0