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UrduThe nasal spray, Spravato has been approved by the FDA for treating depression. …
Tag: FDA Approval
New therapy from UI Health offers FDA-approved treatment option for brittle type 1 diabetes
Lantidra is the only treatment currently approved by the U.S. Food and Drug Administration for the treatment of brittle type 1 diabetes.
FDA approval of new drug regimen helps reduce risk of breast cancer recurrence for patients with early-stage disease
Teri Boudreaux was one of more than 5,000 women who joined a clinical trial that was looking at the benefit of adding the targeted therapy drug ribociclib to conventional hormonal therapy for the adjuvant treatment of HR-positive, HER2-negative early-stage breast cancer. I
What Is Gene Therapy?
Every cell in your body holds a unique genetic code within your DNA, inherited from your parents. The segments of your DNA called genes determine nearly all your body’s characteristics and functions.
As FDA Expands Approval of a New Gene Therapy to Treat Duchenne Muscular Dystrophy, a CHLA Expert Weighs in
After previously approving its use for a limited population, the U.S. Food and Drug Administration has now approved Elevidys, a gene therapy designed to treat Duchenne muscular dystrophy (DMD), for a broader range of child patients.
New Treatment for Uterine Cancer Receives FDA Approval
The U.S. Food & Drug Administration has approved use of a new treatment option for patients with advanced or recurring uterine cancer. The news comes after completion of the first Phase III trial to statistically evaluate an anti-PD1 immunotherapy, called…
Expert available: FDA approval of Alzheimer’s disease drug, donanemab
The FDA approved a new Alzheimer’s disease treatment today called donanemab (brand name Kisunla), after it was reviewed and recommended by an advisory panel earlier this year. Sanjeev Vaishnavi, MD, PhD, an assistant professor of neurology at Penn Medicine, is…
Wren Laboratories Unveils Dynamic Executive Leadership Team and 2024 Commercial Strategy Overhaul
Wren Laboratories announced executive leadership for commercial operations and market expansion. Dr. Abdel Halim is appointed CEO and CSO. Troy Tremaine Appointed to CCO, Dr. Eva Szarek Head of Marketing, and Melissa Ferone director of quality. Expansion includes AI-driven mRNA liquid biopsy genomic assays for biopharma and diagnostics.
UCLA-led research results in FDA approval of 4-drug combination for frontline treatment of metastatic pancreatic cancer
A four-drug chemotherapy regimen of irinotecan liposome (Onivyde) in combination with oxaliplatin, leucovorin, and fluorouracil has been approved by the FDA for the first-line treatment of metastatic pancreatic adenocarcinoma.
FDA Approves Mirikizumab, a Promising Induction and Maintenance Therapy for Ulcerative Colitis
Offers new option with improved quality of life for patients with moderate-to-severely active disease.
Tumor-destroying soundwaves receive FDA approval for liver treatment in humans
The U.S. Food and Drug Administration has approved the use of sound waves to break down tumors—a technique called histotripsy—in humans for liver treatment.
FDA approving drugs after fewer trials, providing less information to public, OSU studies find
The U.S. Food and Drug Administration is approving more novel pharmaceutical drugs based on single clinical trials and with less public disclosure about those trials than was the norm just a few years ago, a pair of recent studies from Oregon State University found.
Pediatrics expert available to comment on FDA approval of first OTC birth control pill
Tracey Wilkinson, an associate professor of pediatrics at the Indiana University School of Medicine, is available to comment on FDA approval of the first over-the-counter birth control pill. She was on the HRA Pharma (maker of the Opill) expert panel…
FDA Grants Alzheimer’s Medication Lecanemab/Leqembi Full Approval, Opening Door For Medicare & Health Insurance Coverage
Hackensack Meridian Health Physicians react to FDA approval of Alzheimer’s drug lecanemab/ Leqembi. Available to discuss its uses, side effects and instances when they have prescribed it.
Lecanemab FDA Approval: U-Mich Alzheimer’s disease expert available and quote #lecanemab
On July 6, the U.S. Food and Drug Administration granted full approval to the new Alzheimer’s disease drug lecanemab (brand name Leqembi). The medication was granted accelerated approval in January. With the landmark decision, University of Michigan Health, Michigan Medicine,…
Annual Medicare spending could increase by $2 to $5 billion if Medicare expands coverage for dementia drug lecanemab
The anti-dementia medication lecanemab and its ancillary costs could add $2 billion to $5 billion in annual Medicare spending if the Centers for Medicare and Medicaid Services (CMS) revise their coverage decision. Currently, the medication is covered only for patients who are enrolled in clinical trials.
Medical experts available: OTC Narcan, Autism Acceptance Month and Black Maternal Health Week
Ochsner Health has medical experts on standby to discuss the groundbreaking FDA approval for over-the-counter Narcan for overdose, many topics related to autism as we promote Autism Acceptance Month in April, including signs of Autism in adults. Black Maternal Health…
“Put profit margins aside,” says Saint Joseph’s University expert on Narcan over-the-counter approval by FDA
Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter after the FDA authorized the move on March 29. Peter A. Clark, S.J., PhD, is the director of the Institute of Bioethics and professor…
Promising new tool for treating migraine headaches — expert available
If you don’t suffer from migraine headaches yourself, chances are you know someone who does. These debilitating headaches commonly effect women between the ages of 25 and 55, and can be known to cause several other symptoms such as nausea…
Chula’s Engineering Develops Dynamic Prosthetic Feet with International Standards and 5 Times Less the Cost
Thailand now has 39,647 people with disabilities, over 95% of whom are using poor-quality prosthetic feet which are heavy and do not have ankles. This can adversely affect the way they walk, as well as their lives.
FDA Approves “Glowing Tumor” Imaging Drug to Aid Lung Cancer Surgery
The U.S. Food and Drug Administration has approved the targeted imaging agent Cytalux (pafolacianine) for use in lung cancer surgery. This injectable diagnostic binds to cancerous tissue and glows when stimulated by near-infrared light, making it easier for surgeons to remove tumors completely while sparing healthy tissue. Thoracic surgeons at the Center for Precision Surgery in the Abramson Cancer Center at Penn Medicine led the clinical trials evaluating the imaging agent in lung cancer, in a partnership with On Target Laboratories.
Vizient Announces Agreement with Ochsner Health Partner SafeSource Direct
Vizient, Inc. today announced an agreement with SafeSource Direct, LLC, the manufacturer of high-quality, American-made personal protective equipment (PPE), for chemo-rated nitrile gloves. The agreement is the latest move by Vizient to increase supply assurance of critical medical supplies.
Deepak L. Bhatt, MD, MPH, Named Director of Mount Sinai Heart
Will also serve as the first-ever Dr. Valentin Fuster Professor of Cardiovascular Medicine
Thermedical Announces FDA Approval of Clinical Trial for SERF Ablation to Treat Patients with Ventricular Tachycardia, Leading Cause of Sudden Cardiac Death
WALTHAM, Mass., Aug. 23, 2022 – Thermedical®, a developer of thermal-ablation systems to treat ventricular arrhythmias, announced today that the U.S. Food & Drug Administration (FDA) has approved an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical® SERF Ablation System with the Durablate® Catheter in people with ventricular tachycardia (VT) resistant to conventional treatment.
Increased Precision and Safety in Spinal Tap with PASS – An Ultrasound-Guided Lumbar Puncture Procedure
PASS (Point-Assisted Spinal Sonography), an ultrasound-guided lumbar puncture device from Chula doctors and engineers, helps increase the precision and confidence in spinal tap procedures while reducing risks and pain for patients.
Chula Researchers Find Extensive amounts of THC in Cannabis-Flavored Drinks The Public Is Cautioned and the Government Urged to Impose Stricter Control
Research work of a biochemistry expert at Chulalongkorn University finds that over 30% of cannabis-flavored drinks randomly tested contain higher THC levels than what is permitted. The public is warned to keep their consumption to moderate levels and that children should refrain from drinking this beverage. The government should control its consumption and warn the people of the benefit and harm of cannabis.
Penn Medicine Developed CAR T Cell Therapy Wins Third FDA Approval
The U.S. Food and Drug Administration (FDA) has expanded its approval for a personalized cellular therapy developed at the University of Pennsylvania’s Abramson Cancer Center, this time for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The accelerated approval was granted today to Novartis for the chimeric antigen receptor (CAR) T-cell therapy Kymriah® (tisagenlecleucel), making it the third indication for the nation’s first personalized cellular therapy for cancer. It remains the only CAR-T cell therapy approved for both adult and pediatric patients.
CSU Statement on FDA’s Full Approval of Pfizer’s COVID-19 Vaccine
California State University Chancellor Joseph I. Castro released the following statement on the FDA’s approval of the Pfizer vaccine.
Light-Activated Dental Materials – the Latest Dental Innovation of International Standards from Chula
Chula Faculty members joined forces in dental materials science to develop easy-to-use “light-activated dental materials” that meet international standards and help shorten tooth filling time. The secret of these innovative dental materials, made by Thai people, is Acemannan polymer from Aloe Vera that can stimulate the formation of dentin and reduce tooth sensitivity in many dental health products.
Johns Hopkins Drug Commercialization Expert Looks at Controversy over Alzheimer’s Treatment
Johns Hopkins Carey Business School Senior Lecturer Supriya Munshaw – an expert in the commercialization of early-stage technologies, especially in the life science and medical device industries – offers her insights into the FDA’s rationale for approving the Alzheimer’s drug aducanumab, the price set by Biogen, the future of FDA leadership, and other related topics, in this Q&A.
FDA-Approved Schizophrenia and Bipolar I Disorder Treatment Includes Compound Discovered at Rensselaer
The U.S. Food and Drug Administration has approved a new drug for treating schizophrenia and bipolar I disorder that includes samidorphan, a new chemical entity discovered at Rensselaer Polytechnic Institute.
Rutgers Pediatric Infectious Disease Expert Available to Discuss Pfizer’s Vaccine Approved by FDA for Children
Pediatric infectious disease expert David Cennimo is available to discuss the Food and Drug Administration approving Pfizer’s COVID-19 vaccine for emergency use on kids ages 12 to 15. “The Pfizer vaccine had a great track record of safety and success since…
Repurposing Tocilizumab in Scleroderma Patients May Prevent Early Lung Disease
A phase 3 clinical trial finds an anti-inflammatory drug used in rheumatoid arthritis can preserve lung function in patients with systemic sclerosis.
The University of Kansas Cancer Center Among the First to Offer CAR T-cell Therapy to Treat Multiple Myeloma
The University of Kansas Cancer Center is the first and only site in the region to offer CAR T-cell therapy to treat multiple myeloma, a type of blood cancer that affects about 30,000 people each year.
Most dollars spent on top-selling orphan drugs don’t go to treat people with rare diseases
Pharmaceutical companies get special protection from the FDA for orphan drugs aimed at rare diseases, but a study shows high spending for common diseases for some such drugs. Just 21% of the total dollars spent in 2018 on 15 top-selling partial orphan drugs went to the treatment of rare diseases, while more than 70% went to the treatment of common diseases.
Seattle Cancer Care Alliance Selected as an Authorized Treatment Center for BreyanziTM/Liso-Cel CAR T-Cell Treatment
Seattle Cancer Care Alliance (SCCA), the only NCCN-designated cancer center in Washington State, has been selected as an authorized treatment center for the new chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel, also known as liso-cel and by the brand name BreyanziTM. Liso-cel was approved by the U.S. Food and Drug Administration (FDA) on February 5, 2021.
Us Against Alzheimer’s advocacy group must reveal financial conflict of interest to FDA, says Dr. Leslie Norins of Alzheimer’s Germ Quest
Alzheimer’s advocacy groups taint their credibility by not revealing conflicts when they lobby FDA for drug approval
Dana-Farber research supports FDA approval for immunotherapy combination in advanced kidney cancer
An immunotherapy agent combined with a tyrosine kinase inhibitor drug whose clinical testing as a first-line treatment in advanced kidney cancer was led by Toni K. Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, has become a standard therapy.
Rutgers Experts Available to Discuss Moderna Coronavirus Vaccine Rollout
Rutgers medical experts are available to discuss the FDA’s approval of Moderna’s coronavirus vaccine for emergency use and its rollout. The Rutgers New Jersey Medical School is one of only two sites for the Phase 3 trial of the Moderna…
UCLA, UCSF gain FDA approval for prostate cancer imaging technique
The University of California’s two nationally ranked medical centers, UCSF and UCLA, and their nuclear medicine teams have obtained approval from the U.S. Food and Drug Administration to offer a new imaging technique for prostate cancer that locates cancer lesions in the pelvic area and other parts of the body to which the tumors have migrated.
Rutgers Vaccine Expert Available to Discuss Moderna’s FDA Submission
Rutgers’ principal investigator for the Moderna phase 3 coronavirus vaccine clinical trial at Rutgers New Jersey Medical School is available to discuss the drugmaker’s submission of its vaccine to the U.S. Food and Drug Administration for regulatory approval. “It is…
Alzheimer’s Association should reveal financial conflict of interest in urging FDA to approve Biogen drug, says Dr. Leslie Norins, CEO of Alzheimer’s Germ Quest
Biogen tried, and failed, to win FDA committee approval for its anti-amyloid Alzheimer’s drug. The Alzheimer’s Association supported the application but did not reveal significant monies received from the firm.
Contraceptive developed at UIC approved by FDA, offers new option for women
A first-of-its-kind contraceptive developed at the University of Illinois Chicago has been approved by the U.S. Food and Drug Administration. The new contraceptive, called Phexxi, is a non-hormonal vaginal gel that can be used on-demand to prevent pregnancy.
Redesigning Hand Sanitizer and Donating 7,000 Gallons to Fight Covid-19
Notice how hand sanitizer has made a comeback? It was running out, but this charitable initiative helped revive it by tapping into ethyl alcohol and FDA approval.