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September 19, 2022

FDA Fast Tracks Approval of Therapy for Rare Neurologic Disorder FDA Fast Tracks Approval of Therapy for Rare Neurologic Disorder

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

EU Panel Backs New Drug for Infant Immunization of RSV EU Panel Backs New Drug for Infant Immunization of RSV

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

FDA Okays Terlipressin (Terlivaz) for Hepatorenal Syndrome FDA Okays Terlipressin (Terlivaz) for Hepatorenal Syndrome

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

NY Gov Declares State Disaster Emergency Over Polio NY Gov Declares State Disaster Emergency Over Polio

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

FDA Warns of Clip Lock Malfunctions With MitraClip Devices FDA Warns of Clip Lock Malfunctions With MitraClip Devices

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

FDA Warns of Cancer Risk in Scar Tissue Around Breast Implants FDA Warns of Cancer Risk in Scar Tissue Around Breast Implants

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

ALS Drug Gets FDA Panel Thumbs Up After Rare Second Look ALS Drug Gets FDA Panel Thumbs Up After Rare Second Look

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

FDA Approves Durvalumab Plus Chemo for Biliary Tract Cancer FDA Approves Durvalumab Plus Chemo for Biliary Tract Cancer

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

FDA Okays First Treatment for Generalized Pustular Psoriasis FDA Okays First Treatment for Generalized Pustular Psoriasis

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), […]
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