Food and Drug Administration (FDA) News 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.FDA Roundup: April 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 - April 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA approves Roche ’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer
Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC)1This approval helps address an urgent unmet need, with abouthalf of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy2TheNational Comprehensive Cancer Network ® (NCCN®)Guidelines recommend routine testing for ALK, EGFR and PD-L1 biomarkers in people with early-stage NSCLC to inform adjuvant therapy selectionBasel, 19 April 2024 - Roche (SIX: RO,...
Source: Roche Investor Update - April 19, 2024 Category: Pharmaceuticals Source Type: news
FDA approves Roche ’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer
Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC)1This approval helps address an urgent unmet need, with abouthalf of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy2TheNational Comprehensive Cancer Network ® (NCCN®)Guidelines recommend routine testing for ALK, EGFR and PD-L1 biomarkers in people with early-stage NSCLC to inform adjuvant therapy selectionBasel, 19 April 2024 - Roche (SIX: RO,...
Source: Roche Media News - April 19, 2024 Category: Pharmaceuticals Source Type: news
Salmonella prompts Trader Joe's to recall basil sold in 29 states
and the Food and Drug Administration (FDA) are warning consumers not to eat Infinite Herbs brand organic basil sold at Trader Joe's due to a salmonella outbreak. The organic basil from Infinite Herbs was packaged in 2.5-ounce clamshell packaging and was sold at Trader Joe's stores in 29 states and…#fda #infiniteherbs #districtofcolumbia #traderjoe #connecticut #delaware #florida #georgia #iowa #illinois (Source: Reuters: Health)
Source: Reuters: Health - April 19, 2024 Category: Consumer Health News Source Type: news
U.S. FDA Approves Subcutaneous Administration of Takeda ’s Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
OSAKA, Japan April 19, 2024 and CAMBRIDGE, Massachusetts, April 18, 2024– Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Entyvio® (vedolizumab) subcutaneous (SC) administration for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 18, 2024 Category: Drugs & Pharmacology Source Type: news
US FDA Mandates Label Updates on CAR-T Cancer Therapies US FDA Mandates Label Updates on CAR-T Cancer Therapies
The U.S. Food and Drug Administration said on Thursday cancer therapies that use CAR-T technology will require changes to the so-called " boxed warning " to highlight the...Reuters Health Information (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - April 18, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 18, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Lumicell's Lumisight, LumiSytem get FDA nods
Lumicell's Lumisight (pegulicianine) optical imaging agent has been approved by a new drug application (NDA) by the U.S. Food and Drug Administration (FDA).
The FDA has also granted premarket approval for the company's LumiSystem, Lumicell's direct visualization system. Both Lumisight and LumiSystem previously received FDA Fast Track and Breakthrough Device designations.
LumiSystem allows surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries. Its combination with Lumisight is indi...
Source: AuntMinnie.com Headlines - April 18, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news
FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer
South San Francisco, CA -- April 18, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 18, 2024 Category: Drugs & Pharmacology Source Type: news
Reports of Injuries, Deaths Prompt FDA to Recall Heart Failure Devices
WEDNESDAY, April 17, 2024 -- The HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, are now under a strict U.S. Food and Drug Administration recall after being tied to 273 known injuries and 14... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 17, 2024 Category: Pharmaceuticals Source Type: news
Eli Lilly Says Zepbound Can Ease Obstructive Sleep Apnea
WEDNESDAY, April 17, 2024 -- Eli Lilly announced Wednesday that in two company trials, Zepbound was found to ease sleep apnea in adults with obesity.First approved to treat obesity by the U.S. Food and Drug Administration last November, the power... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 17, 2024 Category: Pharmaceuticals Source Type: news
Ossos-Sans contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Ossos-Sans, a product promoted and sold for pain on various websites, including https://alnaturaleshop.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 17, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Classifies Recall of Boston Scientific Device as'Most Serious'FDA Classifies Recall of Boston Scientific Device as'Most Serious '
The U.S. Food and Drug Administration on Wednesday classified a recall of Boston Scientific ' s device used to block blood flow during excessive bleeding or hemorrhaging as...Reuters Health Information (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - April 17, 2024 Category: Internal Medicine Tags: Gastroenterology News Source Type: news
PET tracer for gliomas under expedited review
The U.S. Food and Drug Administration (FDA) has granted fast-track designation to Telix Pharmaceuticals’ PET radiotracer F-18 floretyrosine (Pixclara) for imaging progressive or recurring gliomas.
Pixclara was developed by researchers at the University of California, San Francisco. The tracer reveals the activity of specific transporter proteins known as LAT1 and LAT2, which are highly active in brain regions with gliomas. The technique can help determine if a glioma is truly progressing or undergoing a treatment-induced change, known as pseudo-progression, where standard MRI is often inconclusive, the company said.
Pi...
Source: AuntMinnie.com Headlines - April 17, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Molecular Imaging Source Type: news
No, You Don ’ t Need to Chug Olive Oil
Forget morning coffee. Across the internet, people are broadcasting a different routine: drinking a shot of extra virgin olive oil after they climb out of bed.
Gulping down the oil that’s usually reserved for cooking has been a “gamechanger,” one TikToker said. “It gives my body a kickstart,” another chimed in. Others claim a shot (or more) of olive oil per day improves their gut health, boosts their metabolism, and makes their skin glow. Even celebrities, like Kourtney Kardashian and Ryan Seacrest, have trumpeted their love of olive oil shots.
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Source: TIME: Health - April 17, 2024 Category: Consumer Health News Authors: Angela Haupt Tags: Uncategorized Evergreen healthscienceclimate Source Type: news
