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FDA Roundup: March 19, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for Iclusig (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL
OSAKA, Japan and CAMBRIDGE, Massachusetts, March 19, 2024– Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig® (ponatinib) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Approves Edurant PED (rilpivirine) for Certain Pediatric Patients Living with HIV-1
Titusville, NJ (March 19, 2024)– Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Edurant® PED (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2024 Category: Drugs & Pharmacology Source Type: news

FDA clears inHeart ’s digital twin of the heart
France-based medical device developer inHeart has received clearance from the U.S. Food and Drug Administration (FDA) for its AI-driven digital twin of the heart. The company’s AI software module offers interactive 3D models of the heart generated by AI that analyzes preprocedural CT or MR images. The technology has been proven useful in preplanning ventricular tachycardia ablations, a treatment for a type of irregular heartbeat, the company said. While the software has been commercially available to clinicians in Europe, FDA clearance now allows inHEART to market the product to hospitals across the U.S. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 19, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia
On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy f (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves First Drug to Treat Yeast Ear Infections in Dogs, DuOtic
TUESDAY, March 19, 2024 -- The U.S. Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs. DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 19, 2024 Category: General Medicine Source Type: news

Cell therapy approach harnesses the immune system in a different way to stop cancer
A new cancer treatment that uses a person’s own immune cells has been approved by the U.S. Food and Drug Administration (FDA) for treating the most dangerous type of skin cancer. Now this form of cellular therapy (tumor-infiltrating lymphocyte - or TIL therapy) is showing promise in advanced lung cancers through clinical trials underway at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James). (Source: World Pharma News)
Source: World Pharma News - March 19, 2024 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

FDA Approves Expanded Generalized Pustular Psoriasis Indications for Spevigo
Ingelheim, Germany, March 19, 2024 -- Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has approved Spevigo (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2024 Category: Drugs & Pharmacology Source Type: news

Sequel ’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance
MANCHESTER, N.H., March 18, 2024 (GLOBE NEWSWIRE) -- Sequel Med Tech, LLC, a company developing state-of-the-art insulin delivery technologies, today announced its partner, DEKA Research & Development Corp., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the…#manchester #nh #sequelmedtech #llc #fda #aid #cgm #alanlotvin #tidepoolloop #tidepool (Source: Reuters: Health)
Source: Reuters: Health - March 19, 2024 Category: Consumer Health News Source Type: news

FDA Approves First CAR T-Cell Therapy for Adults With Leukemia or Lymphoma
MONDAY, March 18, 2024 -- The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel [liso-cel]) as the first CD19-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed or refractory... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 18, 2024 Category: Pharmaceuticals Source Type: news

FDA Approves First CAR T-Cell Therapy for Adults With Leukemia or Lymphoma, Breyanzi
MONDAY, March 18, 2024 -- The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel [liso-cel]) as the first CD19-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed or refractory... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 18, 2024 Category: Pharmaceuticals Source Type: news

The Most Exciting New Advances in Managing COPD
The Global Initiative for Chronic Obstructive Lung Disease, or GOLD, is the world’s preeminent COPD research and advocacy organization. Founded in 1997 in collaboration with the U.S. National Institutes of Health and the World Health Organization, one of GOLD’s stated aims is to “improve prevention and treatment of this lung disease.” In its 2023 global strategy report, GOLD changed its definition of COPD—which many in the profession viewed as overdue. Specifically, the new definition emphasized the heterogeneity of COPD in terms of its underlying drivers and long-term disease course. [ti...
Source: TIME: Health - March 18, 2024 Category: Consumer Health News Authors: Markham Heid Tags: Uncategorized freelance Source Type: news

Attitudes toward extended-release naltrexone treatment for opioid use disorder among African Americans - Rigg KK.
BACKGROUND: Extended-release naltrexone (XR-NTX; Vivitrol ®) is a long-acting injectable form of naltrexone, which is a medication used to treat opioid use disorder (OUD). In 2010, XR-NTX received Food and Drug Administration approval to treat OUD, becoming... (Source: SafetyLit)
Source: SafetyLit - March 18, 2024 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

Walmart nuts RECALLED in 30 US states over potentially fatal allergies
An in-store brand of Walmart's 'honey roasted' cashews have been recalled in 30 US states and from their online retail site due to the risk of potentially fatal allergies. The US Food and Drug Administration (FDA) issued the notice Wednesday, warning consumers that 'a limited amount' of 8.25 oz…#walmart #fda #vermont #johnbsanfilipposon #squirrelbrand #southernstylenuts #jbss #upc #annalsofallergy #mayoclinic (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2024 Category: Consumer Health News Source Type: news

Madrigal wins first U.S. approval for drug to treat liver disease MASH
The Food and Drug Administration on Thursday approved the first medicine developed specifically to treat the serious liver disease known as MASH. The pill, called Rezdiffra, is made by Madrigal Pharmaceuticals. Metabolic…#rezdiffra #metabolic (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2024 Category: Consumer Health News Source Type: news