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.
Offers new option with improved quality of life for patients with moderate-to-severely active disease.
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.
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.
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…
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.
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,…
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.
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…
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…
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…
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.
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, 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.
Will also serve as the first-ever Dr. Valentin Fuster Professor of Cardiovascular Medicine
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.
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.
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.
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.
California State University Chancellor Joseph I. Castro released the following statement on the FDA’s approval of the Pfizer vaccine.
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 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.
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.
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…
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 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.
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 (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.
Alzheimer’s advocacy groups taint their credibility by not revealing conflicts when they lobby FDA for drug approval
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 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…
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’ 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…
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.
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.
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.