UGN-102 has the potential to be the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, UroGen says. UroGen has completed its New Drug Application (NDA) submission for UGN-102 (mitomycin) for intravesical solution, suggesting that it has the potential to become the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The NDA submission is supported by results from the Phase III ENVISION trial, which demonstrated that patients treated with UGN-102 had a 79.6% complete response (CR) rate at three months following the first instillation.1.

UroGen Pharma Submits FDA New Drug Application for UGN-102, a Potential Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Neffy nasal spray is the first FDA approved needle-free epinephrine alternative. The spray is as effective as autoinjectors. Patients who are afraid of needles may be more inclined to carry the spray. Advocates were pleased to learn about the FDA’s approval of ARS Pharmaceuticals’ neffy epinephrine nasal spray, which may...

Advocates ‘very excited’ by FDA approval of epinephrine nasal spray

A phase 1b study will investigate PTM-01, a directed administration of paclitaxel, in patients with nonmetastatic pancreatic cancer. The FDA has granted clearance to the investigational new drug (IND) application of PTM-01. A phase 1b study of PTM-01 in pancreatic ductal adenocarcinoma (PDAC) will proceed. PTM-01 is a proprietary flexible...

FDA Clears IND Application of Novel Paclitaxel Administration in Pancreatic Cancer

In this episode of Targeted Talks, Edwin Choy, MD, PhD, discussed the FDA approval of afamitresgene autoleucel for the treatment of patients with advanced synovial sarcoma. In this episode of Targeted Talks, Edwin Choy, MD, PhD, director of the sarcoma program at the Division of Hematology Oncology at Massachusetts General Hospital, a founding member of Mass General Brigham, and associate professor of medicine at Harvard Medical School, delves into the recent approval of afamitresgene autoleucel (afami-cel; Tecelra) for the treatment of patients with advanced synovial sarcoma.

Breaking New Ground in Synovial Sarcoma: Choy on the FDA Approval of Afami-cel

A phase 2 trial will assess BRG01 for the treatment of patients with relapsed/metastatic EBV-positive nasopharyngeal carcinoma. A phase 2 trial evaluating BRG01, an Epstein-Barr virus (EBV)-specific chimeric antigen receptor (CAR) T-cell therapy, will begin. BRG01 is the first cell therapy to enter phase 2 trials in both the US...

FDA Greenlights Phase 2 Trial for BRG01 in EBV+ Nasopharyngeal Carcinoma

Federal drug safety regulators have received nearly 300,000 adverse event reports involving health problems with Ozempic, Wegovy, Mounjaro and similar drugs from the same class of medications, highlighting the growing concerns about side effects associated with the widely used diabetes and weight loss treatments. In a report published last week...

FDA Database Reveals High Number of Severe Adverse Events Involving Problem from Ozempic, Similar GLP1 Drugs

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Longeveron’s experimental cell therapy Lomecel-B for mild Alzheimer’s disease. The designation is designed to accelerate the development and review processes for regenerative medicine candidates, including cell therapies, intended to treat, modify, reverse,...

Lomecel-B granted FDA RMAT status for mild Alzheimer’s

Livdelz is an oral therapy to treat patients with primary biliary cholangitis, a progressive autoimmune disease. It is expected to be available in pharmacies next week. The FDA has granted accelerated approval for Livdelzi (seladelpar) to treat patients with primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). PBC is a progressive autoimmune disease that results from the destruction of the bile ducts in the liver. This leads to inflammation, scarring and cirrhosis. The disease affects mostly women.

FDA Grants Accelerated Approval for Rare Liver Disease Drug

The Food and Drug Administration (FDA) on Aug. 6 approved VORANIGO, the first targeted therapy for Grade 2 Isocitrate dehydrogenase (IDH) mutant glioma, a type of brain tumor. Available to patients as a once-daily pill, VORANIGO is the first significant treatment breakthrough in nearly 25 years for Grade 2 IDH mutant glioma, the drug’s maker Servier explained.

FDA approves Servier’s VORANIGO for certain brain tumors

Florida State

Contributors represent independent, third-party users who have joined our contributor program and self-verified their accounts. They have also demonstrated their experience writing hard news for other outlets. Contributors are expected, like all users, to adhere to our Community Standards.

contributor

Jacksonville Today

Republican Donald Trump has a 7-point lead over Democrat Kamala Harris among Florida voters, 49% to 42%, according to a new poll from the University of North Florida. Four percent are backing another candidate, and 6% are undecided or didn’t answer.

New Florida poll: Trump leads; support strong for abortion and recreational weed

The following is a summary of “Patients With Inflammatory Bowel Disease Are at Increased Risk of Hospitalization Due to Respiratory Syncytial Virus,” published in the August 2024 issue of Gastroenterology by Smith et al. Patients with inflammatory bowel disease (IBD) are at high risk of respiratory infections, including...

Increased Risk of Hospitalization in Patients with IBD Following RSV Infection

Inspire Medical Systems, a medical technology company focused on the development and commercialization of minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced the FDA approval of the Inspire V therapy system which includes the next generation neurostimulator and the associated Bluetooth patient remote and physician programmer. Inspire...

FDA Approves 'Mask-Free' Sleep Apnea Treatment Device

In a recent study, the investigational drug, PIPE-307, effectively induced OPC differentiation and remyelination in MS donor human brain tissue and an animal model and restored lost function in an MS mouse model. Multiple sclerosis (MS) is an autoimmune disease in which aberrant inflammatory processes cause destruction of the protective...

Potential First-in-Class M1R Antagonist May Promote Remyelination and Restore Function in Patients with MS

Enzeevu is biosimilar to Eylea (aflibercept), which was FDA-approved in 2019. Sandoz announced today the FDA approval of biosimilar Enzeevu (aflibercept-abzv) for the treatment of neovascular age-related macular degeneration, according to the details of a news release published this morning. Enzeevu is interchangeable with reference medication Eylea (aflibercept) with unexpired exclusivity. The recommended dose of Enzeevu is a 2 mg intravitreal injection administered every four weeks for the first three months and then every eight weeks for two months.

Biosimilar Enzeevu Approved by FDA to Treat Neovascular Age-Related Macular Degeneration

Writers represent independent, third-party users who have joined our contributor program and self-verified their accounts. Writers are expected, like all users, to adhere to our Community Standards.

writer

J. Souza

According to cruise industry reports, the world's largest cruise ship is sailing well above 100% capacity, thanks to more beds being filled on recent sailings. Royal Caribbean’s newest flagship, the Icon of the Seas, is proving to be an unprecedented success, with occupancy rates far exceeding expectations.

The Largest Cruise Ship in the World is Sailing at 132% Capacity: How This is Even Possible

People are excited to use semaglutide, a diabetes drug popular for assisting weight loss that's commonly sold as Ozempic and Wegovy — and there's good reason to be. But the Food and Drug Administration is now warning the public not to get carried away, issuing an alert that it's received reports of people getting hospitalized after overdosing on the drug, in some cases taking up to 20 times the recommended dosage.

FDA Says People Are Taking 20 Times the Proper Dose of Ozempic and Overdosing

74-year-old man diagnosed 6 months ago with LR-MDS with low-moderate anemia (Hb 11.4 g/dL) No family history of cancer or significant genotoxic agent exposure. Serum EPO – 550m U/L, Ring sideroblast (RS) negative. Hgb: 10.2 g/dL. WBC and ANC: WNL. IPSS-R: Low. Received 2-3 units of blood every month...

ESA-Ineligible LR MDS patient with Transfusion-Dependent Anemia

Colorado State

David Heitz

A bill quietly introduced this spring in the Colorado legislature to decriminalize the possession of drug paraphernalia obtained by harm reductionists has become law. As low-key as the legislation was introduced, the bill was signed into law without fanfare June 6. It garnered little to no media attention.

Colorado legalizes needles, pipes for meth and crack if obtained by harm reduction group

Imfinzi may be used alone, or with chemotherapy in tandem with the other approved treatment, Lynparza. Imfinzi (durvalumab) and Lynparza (olaparib), two AstraZeneca products, have been approved as treatments for certain people who have primary advanced or recurrent endometrial cancer throughout the European Union (EU), AstraZeneca said in a press release on Aug. 14, 2024 (1). The European Commission’s approval follows a positive opinion by the Committee for Medicinal Products for Human Use based on a subgroup analysis of mismatch repair (MMR) status in a Phase III trial (DUO-E), the results of which were published in the Journal of Clinical Oncology (2).

Two AstraZeneca Treatments for Endometrial Cancer Approved in EU

Denver, CO

In addition to collecting more than 8,000 used needles in the past year from Denver drug users, the Harm Reduction Action Center passed out 10,000 meth pipes and “snort kits,” according to a newsletter sent to its supporters Thursday. They also connected about 1,700 people to medical, mental health and substance abuse treatment.

Denver group hands out 10K meth pipes, ‘snort kits,’ connects 1,700 to treatment annually

NewsBreak

FDA Considers UGN-102 in Low-Grade NMIBC

A new drug application has been submitted to the FDA for UGN-102, an intravesical solution for treating low-grade, intermediate-risk non–muscle-invasive bladder cancer. The FDA has received...

FDA Considers UGN-102 in Low-Grade NMIBC

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