A New Era in Fetal Monitoring Technology: FDA Grants IDE Approval to Raydiant Oximetry’s Lumerah
Raydiant Oximetry has achieved a significant milestone in its journey toward regulatory approval by securing an Investigational Device Exemption (IDE) from the US Food...
FASENRA Receives Approval for Severe Asthma Treatment in Children Ages 6 to 11
AstraZeneca's FASENRA® (benralizumab) has received approval from the US Food and Drug Administration (FDA) as an add-on maintenance treatment for severe asthma patients aged...
Epilepsy Management Enhanced: SK Life Science Announces FDA Approval for Additional XCOPRI® Administration Options
SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals, Co., Ltd., made a significant announcement regarding the approval by the U.S. Food and Drug...
Surgical Robotics Revolution: The US Welcomes the Symani System for Microsurgery
MMI (Medical Microinstruments, Inc.), a renowned company at the forefront of surgical robotics innovation, has unveiled the long-awaited introduction of its groundbreaking Symani Surgical...
President Biden Criticizes High Prices of Asthma Inhalers During White House Speech
President Joe Biden, in collaboration with US Senator Bernie Sanders, underscored his commitment to addressing the issue of high drug prices, particularly focusing on...
New Rule Under Biden-Harris Administration Enhances Medicare Advantage and Part D Access and Protections
Marks a significant milestone as the U.S. Department of Health and Human Services (HHS), under the purview of the Centers for Medicare & Medicaid...
Advancing Sepsis Detection: Prenosis Secures FDA Authorization for Groundbreaking AI Sepsis ImmunoScoreTM
The Food and Drug Administration (FDA) has granted de novo clearance to an innovative artificial intelligence (AI) tool developed by Prenosis, known as the...
First FDA-Approved Digital Therapy for Major Depressive Disorder Unveiled by Otsuka and Click Therapeutics
The U.S. Food and Drug Administration (FDA) has approved Rejoyn, marking a groundbreaking achievement as it becomes the first digital therapeutic authorized for the...
FDA Approves Zevtera for Serious Bacterial Infections, Bolstering Treatment Arsenal Against Antibiotic Resistance
The U.S. Food and Drug Administration (FDA) has approved Zevtera (ceftobiprole medocaril sodium for injection) to treat several serious bacterial infections in adults and...
FDA Expands Fanapt’s Use to Treat Bipolar Disorder, Offering New Hope for Patients
The FDA has approved Vanda Pharmaceuticals' Fanapt (iloperidone) to treat acute manic or mixed episodes associated with bipolar disorder in adults. This expanded indication...
Infutronix Halts Distribution of Infusion Pumps in the US Following Surge in Complaints
Infutronix, a medical device manufacturer, has initiated a recall of its Nimbus Infusion Pump Systems from the market in response to a significant number...
Baxter’s Novum IQ Infusion Pump Wins FDA Nod After Rigorous Review, Sets Stage for Market Growth
Baxter, a leading healthcare company, made a significant announcement on Monday regarding the 510(k) clearance received from the U.S. Food and Drug Administration (FDA)...
FDA Updates Mammography Facility Standards with New Breast Density Notification Requirements
The U.S. Food and Drug Administration (FDA) recently issued the Final Rule to Amend the Mammography Quality Standards Act (MQSA) Regulations, introducing updated requirements...
Groundbreaking Workshop to Propel Rare Diseases Treatment Innovations: Reagan-Udall Foundation and Partners
The Reagan-Udall Foundation for the Food and Drug Administration (FDA), in collaboration with several key entities including the FDA's Rare Diseases Team, the Office...
Breast Cancer Brain Metastasis Therapy Utidelone by Biostar Pharma, Received Orphan Drug Designation from FDA
Biostar Pharma has recently announced a significant milestone in its pharmaceutical endeavors with the US Food and Drug Administration (FDA) granting orphan drug designation...
