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Key Takeaways From Supreme Court Arguments on Abortion Pill Access
Several justices questioned the remedy of applying nationwide restrictions to mifepristone because it would be the first time a court had second-guessed the F.D.A. ’s regulatory authority. (Source: NYT Health)
Source: NYT Health - March 26, 2024 Category: Consumer Health News Authors: Pam Belluck Tags: United States Politics and Government Abortion Supreme Court (US) Food and Drug Administration Drugs (Pharmaceuticals) Gorsuch, Neil M Barrett, Amy Coney Jackson, Ketanji Brown (1970- ) Thomas, Clarence Source Type: news

FDA Roundup: March 26, 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 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Avicenna.AI secures FDA clearance for CINA-iPE and CINA-Aspects
Medical imaging AI company Avicenna.AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CINA-iPE and CINA-Aspects software. CINA-iPE is an AI-powered tool that detects incidental pulmonary embolism during routine CT scans. The algorithm identifies lung blood clots detected during routine CT scans for a variety of health conditions. Scan types may include full-body scans, scans of the chest, abdomen, and pelvis, as well as scans of the thoracic area along with the abdomen and pelvis. CINA-Aspects is for stroke severity assessment, automatically processing non-contrast CT scans and cal...
Source: AuntMinnie.com Headlines - March 26, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Roche receives FDA approval for the first molecular test to screen for malaria in blood donors
The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malariaMalaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusionRoche is dedicated to saving patients ’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseasesBasel, 26 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) approval of the cobas® Malaria test for use on the cobas® 6800/8800 Systems. This approved test ca...
Source: Roche Investor Update - March 26, 2024 Category: Pharmaceuticals Source Type: news

Abortion Pill Dispute Centers on Central Question: Who Can Sue?
The parties in the fight over access to the abortion pill sharply disagree on whether anti-abortion doctors and groups can show they will suffer harm. (Source: NYT Health)
Source: NYT Health - March 26, 2024 Category: Consumer Health News Authors: Abbie VanSickle and Pam Belluck Tags: Abortion Abortion Drugs Suits and Litigation (Civil) Doctors United States Politics and Government Food and Drug Administration Supreme Court (US) Source Type: news

The rise of theranostics: Part 1 -- Gaining momentum
Since the U.S. Food and Drug Administration's (FDA) approvals of radiopharmaceuticals for neuroendocrine tumors and then for prostate cancer, theranostics has picked up momentum in clinical practice, propelled by encouraging research.Theranostics pairs diagnostic biomarkers that can be visualized on nuclear medicine imaging with therapeutic agents that share a specific target in diseased cells or tissues. After the therapeutic agent binds to the cancer cells, the tumors are treated in such a way that aims to prevent collateral damage to healthy cells and improve overall outcomes.Theranostics isn’t new; nuclear medicine d...
Source: AuntMinnie.com Headlines - March 26, 2024 Category: Radiology Authors: Liz Carey Tags: Practice Management Molecular Imaging Radiation Oncology/Therapy Nuclear Medicine Source Type: news

Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia
WALTHAM, Mass., March 26, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 26, 2024 Category: Drugs & Pharmacology Source Type: news

IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick Disease Type C
March 26, 2024 -- IntraBio Inc today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for IB1001 for the treatment of Niemann-Pick disease Type C (NPC). The application has been granted Priority... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 26, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Approves Oral Duvyzat for Duchenne Muscular Dystrophy
MONDAY, March 25, 2024 -- The U.S. Food and Drug Administration has approved Duvyzat (givinostat) as an oral medication for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.Duvyzat is a histone deacetylase... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 25, 2024 Category: Pharmaceuticals Source Type: news

Regeneron Provides Update on Biologics License Application for Odronextamab
TARRYTOWN, N.Y., March 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 25, 2024 Category: Drugs & Pharmacology Source Type: news

DNA test says it can predict opioid addiction risk. Skeptics aren ’t so sure.
The Food and Drug Administration approved the test despite an agency committee of experts voting overwhelmingly against recommending approval. (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - March 25, 2024 Category: Consumer Health News Authors: David Ovalle Source Type: news

FDA approves nonsteroidal treatment for Duchenne muscular dystrophy
The U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle. (Source: World Pharma News)
Source: World Pharma News - March 25, 2024 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

GEHC touts FDA clearance of Ionic Health's nCommand Lite
GE HealthCare (GEHC) is touting the U.S. Food and Drug Administration (FDA) clearance of Ionic Health's nCommand Lite software, which GEHC will distribute.nCommand Lite offers remote patient scanning support, remote access for review of images, and the ability to connect off-site experts to hospital-based ones, GEHC said. It supports MR, CT, and PET/CT imaging. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 25, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Lumicell touts Lumisight clinical results
Lumicell highlighted clinical results presented at the recent Society of Surgical Oncology (SSO) in Atlanta, GA, that it says demonstrate the benefits of its Lumisight optical imaging agent for breast cancer. In 2023, the company submitted a new drug application (NDA) for Lumisight for use in patients with breast cancer undergoing a lumpectomy, along with a premarket approval (PMA) application for its Direct Visualization System (DVS). On March 5, the U.S. Food and Drug Administration's (FDA) Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of Lumisight's benefit-risk profile, according to the firm. (S...
Source: AuntMinnie.com Headlines - March 25, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news