Food and Drug Administration (FDA) News 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 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. [time-brightcove not-tgx=”trueR...
Source: TIME: Health - April 17, 2024 Category: Consumer Health News Authors: Angela Haupt Tags: Uncategorized Evergreen healthscienceclimate Source Type: news

Weight-Loss Drugs Help Sleep Apnea Symptoms
Eli Lilly & Co.’s weight-loss drug Zepbound improved breathing problems in highly anticipated studies that may convince more insurers to cover the $1,000-a-month treatment. In two late-stage trials of patients with obstructive sleep apnea, a condition closely linked to obesity, Zepbound reduced the number of times breathing slowed or stopped during sleep by up to 63% from the baseline, Lilly said in a statement Wednesday. The result topped Jefferies analysts’ expectations that the trials would likely show a reduction of about 50% to 55%. [time-brightcove not-tgx=”true”] Patients in...
Source: TIME: Health - April 17, 2024 Category: Consumer Health News Authors: Madison Muller/Bloomberg Tags: Uncategorized bloomberg wire healthscienceclimate Source Type: news

FDA Recalls Heart Failure Devices Linked to Injuries and Deaths
WEDNESDAY, April 17, 2024 -- Two implanted heart devices used by patients in end-stage heart failure are now under a strict U.S. Food and Drug Administration recall, after being tied to 273 known injuries and 14 deaths, the agency said Tuesday. The... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 17, 2024 Category: General Medicine Source Type: news

Former FDA Director to Speak at Executive War College on FDA ’s Coming Regulation of Laboratory Developed Tests
Tim Stenzel, MD, PhD, will discuss what clinical laboratories need to know about the draft LDT rule, FDA memo on assay reclassification, and ISO-13485 harmonization Many clinical laboratories anxiously await a final rule from the US Food and Drug Administration (FDA) that is expected to establish federal policies under which the agency will regulate laboratory […] The post Former FDA Director to Speak at Executive War College on FDA’s Coming Regulation of Laboratory Developed Tests appeared first on Dark Daily. (Source: Dark Daily)
Source: Dark Daily - April 17, 2024 Category: Laboratory Medicine Authors: Jillia Schlingman Tags: Laboratory Management and Operations Laboratory News Laboratory Resources Laboratory Testing News From Dark Daily Pathology and Clinical Laboratory Conferences Abbott Laboratories anatomic pathology Asuragen clinical pathology dark int Source Type: news

Roche ’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeksThe twice-yearly, 10-minute SC injection has the potential to expand the usage of OCREVUS to treatment centres without IV infrastructure or with IV capacity limitationsU.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024Basel, 17 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from the Phase III...
Source: Roche Media News - April 17, 2024 Category: Pharmaceuticals Source Type: news

FDA Adds Fasenra Indication for Severe Asthma in Children
TUESDAY, April 16, 2024 -- The U.S. Food and Drug Administration has approved an additional indication for Fasenra (benralizumab) as an add-on maintenance treatment for patients aged 6 to 11 years with severe asthma and an eosinophilic... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 16, 2024 Category: Pharmaceuticals Source Type: news

FDA Roundup: April 16, 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 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news