September 19, 2022
The US Food and Drug Administration (FDA) has granted accelerated approval to the novel gene therapy elivaldogene autotemcel (Skysona, bluebird bio) for the treatment of cerebral […]
September 16, 2022
The European Medicines Agency’s human medicines committee on Friday recommended marketing authorization for an immunization against respiratory syncytial virus (RSV) for newborns and infants. The agency’s […]
September 16, 2022
The US Food and Drug Administration (FDA) has approved terlipressin (Terlivaz), the first and only drug approved for patients with hepatorenal syndrome (HRS). HRS is characterized […]
September 9, 2022
New York Governor Kathy Hochul declared a state disaster emergency on Friday after the polio virus has been detected in another county. The order allows EMS […]
September 8, 2022
The US Food and Drug Administration is alerting healthcare providers about the potential for clip lock malfunctions with Abbott’s MitraClip’s delivery system. “These events appear to […]
September 8, 2022
The US Food and Drug Administration (FDA) has issued a safety alert, warning of a rare but concerning potential risk of squamous cell carcinoma (SCC) and […]
September 8, 2022
In a rare second review of a new drug application, a US Food and Drug Association (FDA) advisory panel has voted to recommend approval of a […]
September 5, 2022
The US Food and Drug Administration (FDA) has approved durvalumab (Imfinzi) for use in combination with gemcitabine and cisplatin for adult patients with locally advanced or […]
September 2, 2022
The US Food and Drug Administration (FDA) has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), […]