About 16,985 results

FDA Accepts Resubmitted BLA for Bimekizumab for Plaque Psoriasis
Clinical Advisor

Jan 11th, 2023 - The Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque . Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F. UCB, the drug manufacturer, originally submitted the BLA in , which included data f...

FDA Allows Certified Retail Pharmacies to Dispense Mifepristone
Clinical Advisor

Jan 5th, 2023 - The Food and Drug Administration (FDA) has modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program allowing certified retail pharmacies to dispense the progestin antagonist for medical termination of pregnancy through 10 weeks gestation (70 days or less since the first day of the last menstrual period). Prior to this update, was only available through certain health car...

Actemra Approved for Treatment of Hospitalized COVID-19 Patients
Clinical Advisor

Dec 22nd, 2022 - The Food and Drug Adminsitration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The approval was supported by data from 4 randomized, controlled studies that evaluate...

FDA Clears Two Biomarker Assays for Early Alzheimer's Detection

Dec 9th, 2022 - The US Food and Drug Administration (FDA) has approved two assays that reliably measure two biomarkers of Alzheimer's disease (AD) in cerebrospinal fluid (CSF) — beta-amyloid and tau proteins. Roche's Elecsys beta-amyloid (1-42) CSF II and Elecsys phospho-tau (181P) CSF assays are intended for use in adults aged 55 and older who are being evaluated for cognitive difficulties. "As changes in the...

FDA Okays Dexcom G7 Continuous Glucose Monitoring System

Dec 8th, 2022 - The US Food and Drug Administration (FDA) has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older, and for use during pregnancy. The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to t...

e-Cigarette Maker Juul Reaches Settlement With Nearly 10,000 Plaintiffs

Dec 8th, 2022 - (Reuters) - e-Cigarette maker Juul Labs on Tuesday said it has reached settlements with about 10,000 plaintiffs covering more than 5,000 cases in California. Juul did not disclose the settlement amount as part of the settlement and court process in the federal multidistrict litigation and related JUUL Labs Product Cases. The company has obtained equity investment to fund it, a spokeperson told ...

Narcan Nasal Spray Gets Priority Review for OTC Treatment of Opioid Overdose
Clinical Advisor

Dec 7th, 2022 - The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Narcan®(naloxone HCl) Nasal Spray as an for known or suspected opioid overdose. is an antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. In 2015, the FDA approved Narcan Nasal Spray as a prescription medication indica...

States' Push to Legalize Psychedelics Gaining Momentum

Dec 7th, 2022 - The push to legalize psychedelic drugs is gaining momentum in states across the country, with a sevenfold increase in the number of decriminalization bills since 2019, new research shows.   Researchers identified 74 bills and referendums in 25 states introduced during the study period that either sought to reform existing laws and expand access to psychedelic drugs such as psilocybin (psychedel...

Valneva "on Track" With Chikungunya Vaccine After Positive Data

Dec 6th, 2022 - PARIS (Reuters) - Vaccines company Valneva on Monday reported positive 12-month antibody persistence data for its single-shot Chikungunya vaccine candidate. The firm said in a statement it was currently on track to complete its submission for license application with the U.S. Food and Drug Administration (FDA) by the end of the year. Chikungunya is a viral disease transmitted to humans by infec...

FDA Issues Updated Safety Alert on Endologix AAA Repair Grafts

Dec 6th, 2022 - The US Food and Drug Administration (FDA) has issued an update to its January 2022 safety communication on the use of Endologix AFX endovascular grafts to treat patients with abdominal aortic aneurysm (AAA). The update includes the following new information in the patient labeling for the AFX2 device: An increase in the rate of type III endoleaks was detected with previous iterations of the AFX...

FDA Tweaks Impella Indications on Basis of Post-Approval Study

Dec 5th, 2022 - The US Food and Drug Administration (FDA) has updated the Abiomed Impella RP System's approved indications in a way that "better reflects the characteristics of the patients who may benefit the most from treatment with the device," the agency has announced. The revised language reflects the final results of a post-approval study in which survival rates for patients who met the premarket-study e...

FDA Expands List of Getinge IABP System and Component Shortages

Dec 2nd, 2022 - The US Food and Drug Administration (FDA) today issued a letter to healthcare providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components. Earlier this week, the agency announced shortages of the company's Maquet/Datascope IAB catheters, new Cardiosave IABP devices, and Cardiosave IABP parts. The new notification adds Getinge Maquet/Datasco...

FDA Approves Olutasidenib (Rezlidhia) for Certain Patients With AML

Dec 2nd, 2022 - The US Food and Drug Administration (FDA) has approved olutasidenib (Rezlidhia) for use in certain patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). Specifically, the drug is approved for use in patients who have R/R AML with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by an FDA-approved test. The FDA also approved the Abbott RealTime IDH1 Assay t...

Top Recent FDA Approvals
Clinical Advisor

Dec 1st, 2022 - The US Food and Drug Administration (FDA) approved several drugs relevant to conditions often treated by nurse practitioners and PAs. Approvals include treatments for hemophilia B, acute low back pain, postoperative nausea and vomiting, multiple myeloma, and fibromyalgia pain. Gene Therapy for Hemophilia B The first gene therapy for adults with hemophilia B (congential Factor IX deficiency) has...

FDA OKs First Fecal Transplant Therapy for Recurrent C difficile

Dec 1st, 2022 - The US Food and Drug Administration (FDA) has approved the first fecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people aged 18 years and older. Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrenc...

Can Cannabis Help Patients With MS?

Dec 1st, 2022 - This transcript has been edited for clarity. Anne Cross, MD: Hello. I'm Anne Cross. Welcome to Medscape's InDiscussion series on multiple sclerosis. And today we're going to take on the somewhat controversial topic of the use of cannabis and cannabinoids in the treatment of symptoms in patients with multiple sclerosis. We have an expert to speak to us today about this, Dr Jacquelyn Bainbridge, ...

History of the FDA: An Oncologist Gives an Inside Look 

Dec 1st, 2022 - In Mikkael Sekeres' latest book Drugs and the FDA: Safety, Efficacy, and the Public's Trust (The MIT Press, 2022) he provides an inside look at how the FDA regulates drug approvals and the complexity of the process. Sekeres tells this story by recalling his time spent on the Oncologic Drugs Advisory Committee (ODAC) during the controversial 2011 hearings that looked at whether the breast cancer...

Has Your COVID Test Really Expired?

Nov 29th, 2022 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. You don't necessarily have to throw away that at-home COVID-19 test just because the expiration date on the package has passed. Sometimes the U.S. Food and Drug Administration extends expiration dates after the packages have been shipped because new information on the product's stability has bee...

Atezolizumab (Tecentriq) Bladder Cancer Indication Withdrawn in US

Nov 29th, 2022 - Atezolizumab (Tecentriq) is no longer approved in the United States for use in certain patients with bladder or urinary tract cancer. The drug is an anti-PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma. The manufacturer, Genentech, announced that it was voluntarily withdrawing the US indication for atezolizumab that covered its use in  a...

'Modest' Benefit for Lecanemab in Alzheimer's, Adverse Events Common

Nov 29th, 2022 - UPDATED November 30, 2022 // Editor's note: This article has been updated with additional comments. SAN FRANCISCO — Widely anticipated data from a phase 3 trial of the monoclonal antibody lecanemab suggest the drug "modestly" relieved cognitive impairment in patients with early Alzheimer's disease (AD) — but at a cost. In the CLARITY AD trial, adverse events (AEs) were common compared with plac...