FDA Approvals News Monitoring

FDA Approves Premarket Approval Application for OraQuick HIV Self-Test, Expanding Access to Adolescents

The OraQuick In-Home HIV Test (Orasure Technologies Inc) received approval from the FDA for a premarket approval application 180-say supplement requesting a labeling change to lower the approved age to individuals who are 14 to 17 years of age and older. …

FDA approves weight loss drug Zepbound to treat obstructive sleep apnea

The Food and Drug Administration has authorized the use of Zepbound for adults with obesity and moderate to severe obstructive sleep apnea. Getty Images/iStockphoto hide caption toggle caption Getty Images/iStockphoto The weight loss drug Zepbound …

Federal officials approve use of Eli Lilly obesity drug Zepbound for treating sleep apnea

The Food and Drug Administration on Friday approved the use of Eli Lilly medicine Zepbound, already prescribed for weight loss, as a treatment for sleep apnea in obese patients. The active chemical in Zepbound, tirzepatide, is also prescribed for treating …

FDA Approves First Prescription Drug for Obstructive Sleep Apnea

Sat 21 Dec 2024 | 05:58 PM The US Food and Drug Administration (FDA) has approved Zepbound, the first prescription medication for treating obstructive sleep apnea (OSA), marking a major breakthrough in addressing this widespread sleep disorder. Zepbound, …

FDA Grants Jemperli Breakthrough Therapy Designation in dMMR/MSI-H Rectal Cancer

Treatment with Jemperli (dostarlimab-gxly) has received a breakthrough therapy designation (BTD) from the Food and Drug Administration (FDA) for patients with locally advanced mismatch repair deficient (dMMR), microsatellite instability-high (MSI-H) rectal …

FDA Issues Complete Response Letter for Much-Anticipated GLP-2 Analog

FDA officials issued a complete response letter to Zealand Pharma A/S, the company developing the long-acting glucagon-like peptide-2 (GLP-2) analog glepaglutide for adults with short bowel syndrome (SBS) with intestinal failure who are dependent on …

FDA approves first-ever medication for obstructive sleep apnea

The Food and Drug Administration announced late Friday that it has approved Zepbound to treat obstructive sleep apnea for those who are moderately or severely obese. The drug is to be used in conjunction with a reduced-calorie diet and physical activity, …

"100% successful" cancer drug gets landmark FDA approval

Hugely promising cancer drug dostarlimab is one step closer to being widely available, after the Food and Drug Administration granted it Breakthrough Therapy Designation status that, if successful, will expedite its path to market. Dorstarlimab (brand name …

FDA approves weight-loss drug Zepbound to treat sleep apnea

Phillip Morris sues FDA over new cigarette warning labels

The largest U.S. tobacco manufacturer, Philip Morris USA, is suing the federal government in an attempt to block new graphic labels that will be required on all cigarette packaging and advertising beginning Dec. 12, 2025. The maker of top-selling U.S. …

Popular Dog Arthritis Medication May Have Severe Side Effects, FDA Says

A widely used medication for arthritis in dogs, Librela, may be connected to serious neurological side effects, such as seizures and loss of muscle control, according to a recent review from the US Food and Drug Administration. The FDA approved the drug …

FDA Approves Alyftrek, Once-Daily CFTR Modulator for Cystic Fibrosis

The FDA approved vanzacaftor/tezacaftor/deutivacaftor (Alyftrek; Vertex Pharmaceuticals) for the treatment of cystic fibrosis (CF) in patients 6 years and older who have at least 1 F508del mutation or another mutation in the CFTR gene that is …

USFDA approves Eli Lilly weight loss treatment Zepbound for obstructive sleep apnea

Indianapolis: Eli Lilly and Company has announced the U.S. Food and Drug Administration (FDA) has approved Zepbound (tirzepatide) as a prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound may help …

Neurizon submits IND application for its lead candidate, NUZ─001 with US FDA to support HEALEY ALS platform trial

Neurizon, a clinical-stage biotech company advancing treatments for neurodegenerative diseases, has announced the filing of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its lead candidate, NUZ-001. This …

U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the ...

Company announcement – No. 51 / 2024 U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome The FDA concluded that Zealand Pharma’s application did not meet …

Regulators approve first drug treatment for obstructive sleep apnea

U.S regulators have approved the first drug treatment for moderate to severe obstructive sleep apnea (OSA) in adults with obesity. The U.S Food and Drug Administration (FDA) on Friday, December 19 said that Zepbound (tirzepatide) will be used in …

Eli Lilly given US approval to treat sleep disorder with weight-loss drug

Unlock the Editor’s Digest for free Roula Khalaf, Editor of the FT, selects her favourite stories in this weekly newsletter. US regulators have approved Eli Lilly’s Zepbound to treat adults with both sleep apnoea and obesity, marking a victory for the …

Zepbound Approved For Sleep Apnea

Topline The Food and Drug Administration approved Zepbound as the first prescription medicine to treat sleep apnea on Friday—marking a significant win for the drug company Eli Lilly, which had Zepbound approved as a weight-loss drug last year. A sign for …

U.S. approves first drug treatment for obstructive sleep apnoea

An injection pen of Zepbound, Eli Lilly’s weight loss drug. File photograph | Photo Credit: REUTERS United States regulators on Friday, December 20, 2024, approved the first drug treatment for sleep apnoea, permitting the use of a weight-loss medication …

HomeCareList.org Launches to Revolutionize Access to Home Care Services

Revolutionary online platform simplifies the search for quality home care, connecting families with trusted agencies while helping providers grow their business PHOENIX, AZ, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- HomeCareList.org …

Combination of Addiction and Mental Health Treatment Improving Recovery Results

Integrated treatment programs combining addiction and mental health care deliver superior outcomes, reducing relapse rates and transforming recovery practices. NEW ORLEANS, LA, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- In a …

Scottsdale Practice Embraces Advanced Technology to Shape the Future of Cosmetic Dentistry

Transform your smile with Arizona's leading cosmetic dental experts. SCOTTSDALE, AZ, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- The integration of advanced technology in cosmetic dentistry is reshaping the patient experience and …

Butterfly Wellness Introduces Shammah: The World's First Psychodermatology Chatbot

This press release is about Butterfly Wellness' Launch of Shammah, the Uk's First Psychodermatology Chatbot for Holistic Skin and Mental Health Support. LONDON, LONDON, UNITED KINGDOM, December 21, 2024 /⁨EINPresswire.com⁩/ -- Butterfly …

Iowa Gov. Kim Reynolds Announces Higley Partners to Receive $2 Million For Addiction Center

Historic Cedar Rapids property to transform into Radix Recovery, a 68-bed addiction center, with $2 million state grant and local partnerships. CEDAR RAPIDS, CO, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- Throughout the decades the …

SurveySlack Launches New Survey Platform to Maximize User Engagement and Feedback

SurveySlack simplifies survey creation with customizable templates, AI-driven questions, real-time analytics, and branching logic to boost engagement. AHMEDABAD, GUJARAT, INDIA, December 21, 2024 /⁨EINPresswire.com⁩/ -- SurveySlack has launched a …

Smile4EverMexico Announces New Single-Visit Tooth Restoration Option

TIJUANA, MEXICO, December 21, 2024 /⁨EINPresswire.com⁩/ -- Smile4EverMexico, a clinic specializing in border dentistry, is pleased to announce it has introduced a new service in dental care: complete tooth restoration treatments that can be …

NHS warns of ‘bargain basement’ BBLs in run up to Christmas

England’s top doctor is warning the public about the risk of ‘bargain-basement’ Brazilian Butt lifts, following a stream of deals being offered by overseas clinics in the run up to Christmas.  The NHS has seen clinics offering 25% discounts, all-inclusive …

NASP Tells Congress and the Incoming Trump Administration: Pharmacies and Patients Can’t Continue to Wait for PBM ...

Washington, DC, Dec. 21, 2024 (GLOBE NEWSWIRE) -- The National Association of Specialty Pharmacy issued the following statement: As the non-profit trade organization representing specialty pharmacies that support patients with significant and complex …

International Non-profits call for mandatory device-based age verification

The International Centre for Missing and Exploited Children is committed to advancing child protection and safeguarding vulnerable children around the world. ALEXANDRIA, VA, UNITED STATES, December 20, 2024 /⁨EINPresswire.com⁩/ -- While the …

Colorado adopts nation-leading standard to cut greenhouse gas emissions from oil and gas

Denver (Dec. 20, 2024): The Colorado Air Quality Control Commission adopted a groundbreaking new rule aimed at significantly further reducing greenhouse gas emissions from the state’s oil and gas industry. The rule addresses emissions from midstream oil …

Heavenly Spa By Westin™ at The Westin® Fort Lauderdale Beach Resort Completes an Elaborate Renovation

Spa Enthusiasts Can Enjoy a Wellness Journey Inspired by Serene Destinations Worldwide with New Treatments, an Infrared Sauna and Exclusive Retail Products FORT LAUDERDALE, FL, UNITED STATES, December 20, 2024 /⁨EINPresswire.com⁩/ -- Heavenly Spa …

Lucid Dreaming Devices Market Forecasted to Reach USD 196.8 Million by 2034, Growing at a CAGR of 5.1% | TMR

The lucid dreaming devices market is gaining traction as individuals seek tools to control and enhance their dream experiences for wellness or research. WILMINGTON, DE, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- The global lucid …

Medical Biomimetics Market Expected to Reach USD 19.3 Billion by 2034, With a CAGR of 6.8% |Transparency Market Research

The medical biomimetics market is advancing as biomimetic technologies offer solutions for tissue regeneration and healing in medical applications. WILMINGTON, DE, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- The global medical …

Lymphedema Diagnostics Market to Reach USD 70.7 Million by 2034, Growing at a CAGR of 4.8% |Transparency Market Research

The lymphedema diagnostics market is expanding with innovative solutions for early detection and management of this chronic condition. WILMINGTON, DE, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- The global lymphedema diagnostics …

Patient Monitoring and Ultrasound Devices Display Market Projected to Exceed USD 10.6 Billion by 2034 | TMR

The market for patient monitoring and ultrasound devices display is growing with advancements in real-time health monitoring and diagnostics WILMINGTON, DE, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- The global patient monitoring and …

Catarina Malmrot's new book, Secrets of Sustainable Leadership, reaches #1 International Bestseller Status

Leadership Expert Catarina Malmrot Shares Her Holistic Approach to Quality Management and Leadership STOCKHOLM, SWEDEN, December 20, 2024 /⁨EINPresswire.com⁩/ -- Catarina Malmrot’s latest book, Secrets of Sustainable Leadership: A Holistic …

Glaucoma Treatment Market 2034: FDA Approval, Clinical Trials, Medication, Companies by DelveInsight

Glaucoma companies are Allergan, Santen Pharmaceutical, D.Western Therapeutics Institute, Kowa Ltd., Alcon, Senju Pharmaceuticals, Otsuka Pharmaceuticals, ETC ALBANY, NY, UNITED STATES, December 20, 2024 /⁨EINPresswire.com⁩/ -- DelveInsight's …

Medical Case Management Market Projected to Reach USD 12.3 Billion by 2034, Growing at a CAGR of 6.1% | TMR

WILMINGTON, DE, UNITED STATES, December 21, 2024 /⁨EINPresswire.com⁩/ -- The global medical case management market is poised for significant growth, driven by the rise in the geriatric population, advancements in telemedicine, and the increasing …

Regional Health Directorate of Ucayali distinguished Ocho Sur for Its Contribution to Healthcare in Local Communities

Ocho Sur was honored by DIRESA Ucayali for improving healthcare access and addressing health issues in remote communities of Nueva Requena and Curimaná PUCALLPA, UCAYALI, PERU, December 20, 2024 /⁨EINPresswire.com⁩/ -- The Regional Directorate of …