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About 16,615 results

Fast Five Quiz: Monkeypox
https://www.medscape.com/viewarticle/981391

Oct 3rd, 2022 - Caused by the same family of viruses (Poxviridae) as the variola virus, monkeypox was discovered in 1958 after outbreaks occurred among research monkeys. It was first identified in humans in 1970. Before the 2022 outbreak, nearly all cases seen outside Africa were linked to the continent via travel or animal export. However, data suggest that men who have sex with men (MSM) account for a sizeab...

FDA Approves Futibatinib (Lytgobi) for Certain Biliary Tract Cancers
https://www.medscape.com/viewarticle/981752

Oct 3rd, 2022 - The US Food and Drug Administration (FDA) has granted an accelerated approval for a new drug, futibatinib (Lytgobi), to be used for patients with a certain type of biliary tract cancer. Futibatinib was granted priority review and breakthrough designation, the agency said in its announcement. Futibatinib is indicated for use in adult patients with previously treated, unresectable, locally advanc...

Ruxolitinib Repigments Many Vitiligo Affected Body Areas
https://www.medscape.com/viewarticle/981758

Oct 3rd, 2022 - Ruxolitinib (Opzelura) cream can help repigment the skin in many body areas affected with vitiligo, researchers reported at the European Academy of Dermatology and Venereology (EADV) 2022 Annual Meeting. Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d'Azur and Centre Hospitalier Universitaire de Nice in France. Indeed, a 50% or greater impr...

CMS Spent $18 Billion on Drugs Without Confirmed Benefits, OIG Report Finds
https://www.medscape.com/viewarticle/981730

Sep 30th, 2022 - The Medicare and Medicaid programs spent more than $18 billion over 3 years on medications for which there was no proof of a significant clinical benefit, a new federal report shows. On Tuesday, the Office of the Inspector General (OIG) for the Department of Health and Human Services released an initial take on its ongoing evaluation of medicines cleared through the US Food and Drug Administrat...

BREEZE-AD-PEDS: First Data for Baricitinib in Childhood Eczema
https://www.medscape.com/viewarticle/981709

Sep 30th, 2022 - The oral Janus kinase (JAK) inhibitor baricitinib appears to improve symptoms of atopic dermatitis (AD) in children aged 2 years and up, as indicated by data from the phase 3 BREEZE-AD-PEDS trial. After 16 weeks of treatment, the primary endpoint ― an Investigators Global Assessment (IGA) score of 0 or 1 with at least a 2-point improvement from baseline ― was met by 41.7% of patients given 2 mg...

Medicare Part B Premium Dips on Alzheimer's Drug Setback
https://www.medscape.com/viewarticle/981657

Sep 29th, 2022 - Medicare Part B premiums will dip in 2023 due to a setback for Biogen Inc.'s Alzheimer's disease medicine, which drew tight payment restrictions because of concerns about its safety and effectiveness. The standard monthly Part B premium will be $164.90 for 2023, a decrease of $5.20 from the 2022 rate, the Centers for Medicare and Medicaid Services (CMS) said this week. Medicare officials increa...

FDA Approves Dupilumab for Treatment of Prurigo Nodularis
https://www.medscape.com/viewarticle/981630

Sep 29th, 2022 - The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers. Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin 4 and interleukin 13 pathways, show significant improvements in both itchiness and lesion counts compared ...

FDA Clears Nexpowder Endoscopic Hemostasis System
https://www.medscape.com/viewarticle/981678

Sep 29th, 2022 - The US Food and Drug Administration has cleared the Nexpowder endoscopic hemostasis system. Nexpowder (Medtronic) uses a noncontact, nonthermal, nontraumatic hemostatic powder that is sprayed through a catheter and that features a proprietary powder-coating technology that helps reduce clogging. This provides improved visibility and control for treating upper gastrointestinal (GI) nonvariceal b...

Early Data Suggest Vaccine Protects Against Monkeypox, but Questions Remain
https://www.medscape.com/viewarticle/981685

Sep 29th, 2022 - UPDATED September 30 , 2022 // Editor's note: This story has been updated with additional information. Unvaccinated people were 14 times more likely to get infected with the monkeypox virus compared with those who had one dose of the monkeypox vaccine, according to data released this week by the Centers for Disease Control and Prevention (CDC). These findings, compiled from monkeypox case data ...

FDA OKs Novel ALS Drug, Despite Unusual Path to Approval
https://www.medscape.com/viewarticle/981686

Sep 29th, 2022 - The US Food and Drug Administration (FDA) has approved sodium phenylbutyrate/taurursodiol (Relyvrio, Amylyx Pharmaceuticals), a novel drug to treat amyotrophic lateral sclerosis (ALS). The approval was expected but comes at the end of an unusual review process that began in March with an initial recommendation from the FDA's Peripheral and Central Nervous System Drugs Advisory Committee not to ...

FDA Puts Avidity's Muscle Disorder Drug Trial on Partial Hold
https://www.medscape.com/viewarticle/981475

Sep 28th, 2022 - (Reuters) -Avidity Biosciences Inc said on Tuesday the U.S. Food and Drug Administration has put a hold on patient enrollment in an early-to-mid-stage trial of its drug to treat a genetic muscle disorder, sending the company's shares down over 15%. The agency put the partial hold after a serious adverse event seen in a patient during the study. California-based Avidity did not disclose any deta...

FDA to Review Fewer Emergency Use Requests for COVID Tests
https://www.medscape.com/viewarticle/981493

Sep 28th, 2022 - (Reuters) - The U.S. Food and Drug Administration said on Tuesday it will now review only a small number of emergency use authorization requests for COVID tests that are likely to have a significant benefit to public health, including fulfilling an unmet need. The agency is revising its COVID-19 test policy in light of the current manufacturing status and number of cases, it said, adding compan...

Despite Benefits, Extended-Interval Pembro Uptake Remains Low
https://www.medscape.com/viewarticle/981498

Sep 27th, 2022 - Uptake of the approved extended-interval dosing regimen for pembrolizumab has been poor, according to a review of Veterans Health Administration data. In April 2020, the US Food and Drug Administration (FDA) approved extended dosing for stand-alone pembrolizumab — 400 mg every 6 weeks instead of the standard dosing of 200 mg every 3 weeks. The shift came, in part, to reduce patient healthcare e...

The COVID-19 Booster's Public Relations Problem
https://www.medscape.com/viewarticle/981491

Sep 27th, 2022 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. With the rollout this month of a new coronavirus booster, U.S. public health leaders once more face the challenge of persuading Americans that they should roll up their sleeves and get another, possibly better, shot targeted at the omicron strain. This has become tougher with each successive vac...

FDA Panel Finds Duvelisib Risks Outweigh Benefits in CLL/SLL
https://www.medscape.com/viewarticle/981388

Sep 26th, 2022 - The risks associated with taking duvelisib (Copiktra) by patients with certain blood cancers appear to outweigh the benefits, a federal advisory panel said on Friday. The US Food and Drug Administration (FDA) issued a warning in late June that the PI3 kinase (PI3K) inhibitor may increase the risk of death and serious side effects among adults with relapsed or refractory chronic lymphocytic leuk...

FDA Clears New AI Device to Aid Polyp Detection
https://www.medscape.com/viewarticle/981422

Sep 26th, 2022 - The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance to a new artificial intelligence (AI)–assisted polyp detection device for use during colorectal cancer screening. In a clinical trial, the detection rate of adenomas by endoscopists who used the device, which is called SKOUT, was 27% higher in comparison with the rate for endoscopists who worked without computer as...

Moderna, Pfizer Seek Authorization for Children's Boosters
https://www.medscape.com/viewarticle/981430

Sep 26th, 2022 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Pfizer/BioNTech and Moderna, the two biggest COVID vaccine makers for the United States, are both seeking emergency authorization from the FDA for bivalent vaccine boosters for children. Pfizer's booster would be for children 5 to 11 who have completed a primary vaccination series, the company s...

FDA Warns of Cybersecurity Risk With Certain Medtronic Insulin Pumps
https://www.clinicaladvisor.com/home/topics/practice-management-information-center/fda-warns-of-cybersecurity-risk-with-certain-medtronic-insulin-pumps/
Clinical Advisor

Sep 23rd, 2022 - HealthDay News — The US Food and Drug Administration is warning patients who use a particular insulin pump system that unauthorized people could access it and change how much insulin a patient receives. The pump at the center of the FDA alert is the Medtronic MiniMed 600 Series Insulin Pump System, including models such as MiniMed 630G and MiniMed 670G. Components such as the insulin pump, cont...

FDA Advisers Recommend Ferring's Fecal Transplant Therapy
https://www.medscape.com/viewarticle/981275

Sep 23rd, 2022 - (Reuters) - A panel of U.S. Food and Drug Administration advisers voted in favor of Ferring Pharmaceuticals' fecal transplant-based therapy to reduce the recurrence of a bacterial infection, bringing the first therapy of its kind closer to approval. The therapy, Rebyota, works by replenishing the good gut bacteria through samples of microbes distilled from faeces of healthy donors, delivered th...

FDA Panel Rebuffs Poziotinib for NSCLC in 9-4 Vote
https://www.medscape.com/viewarticle/981318

Sep 23rd, 2022 - Spectrum Pharmaceuticals Inc experienced a setback in its efforts to win accelerated approval in the US of its experimental drug poziotinib for the treatment of a form of non–small cell lung cancer (NSCLC). On Thursday, a US Food and Drug Administration (FDA) advisory panel voted 9 to 4 against recommending the oral agent, citing concerns regarding the evidence of its clinical benefits. The maj...