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.
Synaptive receives U.S. clearance for Modus IR
The Modus X robotic exoscope. Image courtesy of Synaptive.Toronto, Canada-based firm Synaptive Medical has received U.S. Food and Drug Administration clearance for Modus IR, a near-infrared fluorescence visualization module on its Modus X robotic exoscope.The clearance bolsters the capabilities of Synaptive’s exoscope for use across all neurosurgical procedures, as well as in plastic and ENT surgery, the company said. The newly approved IR mode is used for visualizing indocyanine green (ICG) fluorescent dye. ICG causes blood to fluoresce under infrared light and is used to aid in the visualization of vessels and blood fl...
Source: AuntMinnie.com Headlines - March 27, 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 Media News - March 26, 2024 Category: Pharmaceuticals Source Type: news
FDA Approves Winrevair (sotatercept-csrk) a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension
RAHWAY, N.J.--(BUSINESS WIRE) March 26, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name:... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2024 Category: Drugs & Pharmacology Source Type: news
FDA approves Merck's drug for rare, deadly lung condition
Exterior view of the entrance to Merck headquarters on February 05, 2024 in Rahway, New Jersey. The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from…#merck #rahway #newjersey #winrevair #pah #keytruda #jpmorgan #chrisschott #merckchiefmedical #eliavbarr (Source: Reuters: Health)
Source: Reuters: Health - March 26, 2024 Category: Consumer Health News Source Type: news
US FDA Approves Merck's Therapy for Rare Lung Condition US FDA Approves Merck's Therapy for Rare Lung Condition
The U.S. Food and Drug Administration on Tuesday approved Merck ' s treatment for adults with high blood pressure due to constriction of lung arteries, adding another...Reuters Health Information (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - March 26, 2024 Category: Cardiology Tags: Pulmonary Medicine Source Type: news
FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patients
Toronto, Ontario and Chicago, Illinois-- March 26, 2024 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus ' s supplemental Biologics License Application (sBLA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2024 Category: Drugs & Pharmacology Source Type: news
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