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Finerenone, an investigational agent from a new drug class, just scored a second pivotal-trial win after showing significant benefit for slowing progression of diabetic kidney disease in patients with type 2 diabetes in the FIDELIO-DKD pivotal trial with more than 5700 patients. Top-line results from FIGARO-DKD showed significant benefit for the primary endpoint of cardiovascular
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Treatment for Pulmonary Arterial Hypertension (PAH) Liquidia Resubmits New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension MORRISVILLE, N.C., May 10, 2021 (GLOBE NEWSWIRE) – Liquidia Corporation (NASDAQ: LQDA) announced today that on May 7, 2021, it resubmitted its New Drug Application (NDA) for LIQ861 for the treatment of pulmonary arterial hypertension (PAH). The U.S.
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KENILWORTH, N.J.–(BUSINESS WIRE) May 5, 2021– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive
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News FDA Alerts Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil May 11, 2021 Audience: Consumers May 11, 2021 — Delray Beach, Florida, Yamtun7 is voluntarily recalling all lots of Poseidon Platinum 3500 to the consumer level. FDA analysis has found the product to contain
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“There is only this way that we have established over the months of performing together, and what it is congruent with isn’t ‘ourselves’ but past performances — we’re has-beens at heart, routinely trotting out the old, old act.” — Philip Roth, The Counterlife The counterfactual is a term for what would have happened if not
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One of psychotherapy’s main beliefs is that putting thoughts and feelings into words may produce mental health benefits. Of course, this also applies to cancer patients, who face the countless psychological issues that can arise in the face of a serious illness. Participating in therapy, however, isn’t the only way to give voice to one’s internal world
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Third-generation fluoroquinolones may not pose the same risk to tendon health as earlier-generation agents, the findings of a new study suggest. If confirmed, this will be good news for patients who are allergic to beta-lactam antibiotics and others in whom fluoroquinolones are the antibiotics of choice because of their favorable pharmacokinetic properties and broad-spectrum activity, according
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Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. After 2 consecutive weeks of declines, the number of new COVID-19 cases in children rose slightly, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. The increase was less than 0.6% — 72,067 cases were
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May 10, 2021 — Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued
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BASKING RIDGE, N.J. and SHIRLEY, N.Y., May 6, 2021 /PRNewswire/ — Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has approved a single 1000 mg dose option of Injectafer® (ferric carboxymaltose injection), an iron replacement product, for the treatment of iron deficiency anemia (IDA) in adult
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May 10, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy May 10, 2021 — Novo Nordisk is voluntarily recalling 1,468 product samples listed in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements. This recall only impacts
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In this article 22UA-DE PFE Kathrin Jansen, Pfizer Inc, poses for a portrait in one of her labs in Pearl River, New York. Carlo Allegri | Reuters The mRNA technology used to develop the Pfizer–BioNTech Covid-19 vaccine could also help create “more potent” seasonal flu shots, Kathrin Jansen, head of Pfizer’s vaccine research and development,
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Obsessive-compulsive disorder (OCD) in children and adolescents is associated with impaired education and worse general health later in life. Access to specialist treatment is often limited. According to a study from Centre for Psychiatry Research at Karolinska Institutet in Sweden and Region Stockholm, internet-delivered cognitive behavioral therapy (CBT) can be as effective as conventional CBT.
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A novel gene therapy for severe combined immunodeficiency from adenosine deaminase deficiency (ADA-SCID) restored immune cell counts without death or need for enzyme replacement therapy, researchers reported. Survival without needing to re-initiate pegylated ADA enzyme replacement therapy, or have a rescue allogeneic hematopoietic stem cell transplantation (AHCT), was 95% to 97% at last follow-up at
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MedPage Today Editor-in-Chief Marty Makary, MD, MPH, of Johns Hopkins in Baltimore, and Joshua M. Sharfstein, MD, vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health, discuss whether the pandemic has permanently changed the way the public expects the FDA to operate and the lessons learned with
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This past weekend I had the chance to see some nursing friends I hadn’t seen in a while. All vaccinated and sitting at an outdoor table for brunch, it felt like no time had passed. Of course, over a year had gone by since we were able to sit face-to-face and enjoy each other’s company.
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Have you ever felt like something was on your skin, but looked down to see nothing there? For those with tactile hallucinations, this is a regular, and often disturbing, occurrence, but there are coping strategies to help you through it It’s 1am, I’m laying in bed, and I can feel something crawling over my skin.
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