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The FDA issued a public alert on Tuesday concerning generic versions of a widely-used hair loss drug that is frequently distributed by popular telehealth brands like Hims and Keeps. The agency cited 32 reports of adverse events that involved compounded topical finasteride products, which are “potentially putting consumers at risk.” These events include “erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain.” The alert specifically targets a spray-on formulation of finasteride, the active ingredient also found in the oral drug Propecia. According to the FDA, these topical versions have not received official approval, and no comprehensive safety data has been submitted for them. At this time, the only FDA-approved oral finasteride products are Proscar and Propecia. The warning follows a Wall Street Journal report in March about men who experienced severe side effects after acquiring finasteride through a telehealth company. One of the men, US Army Sgt. Mark Millich, 26, began dealing with anxiety, dizziness and slurred speech — and then things got even worse. His sex drive plummeted, and his genitals shrank and changed shape. His doctor said it was due to the medication. None of the 17 men the WSJ spoke to who had severe side effects from getting the...

The Saudi Food and Drug Authority (SFDA) has approved an innovative biotechnology-based in vitro diagnostic test designed to aid in early detection of Alzheimer's disease by measuring a specific biomarker in blood plasma. This test represents a groundbreaking advancement in medical laboratory diagnostics, significantly enhancing the early detection of neurodegenerative diseases. Introducing a Faster and More Accurate Diagnostic Solution This diagnostic test measures the concentration of the pTau181 protein in a patient’s blood plasma, providing accurate results in under 20 minutes. This innovative technology marks a significant improvement over traditional diagnostic methods for Alzheimer's disease, which often involve invasive and time-consuming procedures such as cerebrospinal fluid (CSF) analysis or expensive positron emission tomography (PET) scans. A Comprehensive Scientific Evaluation Ensuring Regulatory Compliance The SFDA approved a thorough scientific evaluation conducted by a team of experts. This review included a detailed assessment of the device’s technical and clinical documentation, as well as clinical study data, to confirm its safety, efficacy, and reliability in compliance with regulatory requirements and globally recognized standards. Aligning with Saudi Arabia’s National Healthcare Vision The introduction of this biotechnology-based diagnostic solution strategically enhances the local market by equipping the healthcare sector with accurate and reliable tools for early diagnosis. This advancement will...

The U.S. Food and Drug Administration is now providing real-time, daily publication updates on adverse event data from its reporting system. In an effort to modernize and provide transparency on public health, the agency announced at the end of last week that adverse event data from the FDA Adverse Event Reporting System (FAERS) will be published daily. Previously, updates were published on a quarterly basis. "People who navigate the government's clunky adverse event reporting websites should not have to wait months for that information to become public," FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. "We're closing that waiting period and will continue to streamline the process from start to finish." The FAERS contains reports from health care professionals, consumers, and manufacturers on adverse events, serious medication errors, and product quality complaints for prescription drugs and biologics. The public can access the data on the FAERS Public Dashboard. According to the FDA, the agency receives more than 2 million reports on adverse events and medication error reports each year. The shift to daily publication is part of "the FDA's broader data modernization strategy to streamline all of its adverse event reporting systems and increase reporting frequency across all systems to identify...

The U.S. Food and Drug Administration has approved Sanofi's (SASY.PA), opens new tab drug to treat a type of blood disorder, the company said on Friday, in a sign that the French drugmaker's $3.7 billion bet on the treatment could start to pay off. The approval aids the company's broader push to become a power house of rare disease and immunology drugs, as it looks to drive growth beyond its top-selling eczema treatment, Dupixent, on which it partners with Regeneron Pharmaceuticals (REGN.O), opens new tab. Sanofi received access to the oral drug, rilzabrutinib, through its deal for Principia Biopharma in 2020. Leerink analysts expect the treatment to bring in peak sales of $2 billion to $5 billion. Rilzabrutinib, to be sold under the brand name Wayrilz, received approval for use in adult patients with the condition known as persistent or chronic immune thrombocytopenia (ITP) who have stopped responding to prior treatments. Sanofi plans to make the drug available to U.S. patients in September. The drugmaker has set a list price of $17,500 for a month's supply of the treatment, but actual costs for patients will vary based on their insurance plans. The condition is a rare blood disorder in which the immune system mistakenly...

The U.S. Food and Drug Administration has approved Teva Pharmaceuticals’ cheaper generic version of Novo Nordisk’s older weight-loss drug, Saxenda, the Israel-based company said on Thursday. Saxenda, chemically known as liraglutide, belongs to the first generation of GLP-1 drugs, which curb appetite as well as help control blood sugar. This results in less weight loss on average than Novo’s popular newer treatment, Wegovy. The FDA approval makes Teva’s version the first generic GLP-1 drug indicated for weight loss in the U.S., the company said. Saxenda is approved for obese adults with weight-related medical problems and pediatric patients aged 12 to 17 years who weigh more than 60 kg and have obesity.

As a result of years of collaborative efforts with King Faisal Specialist Hospital and Research Centre (KFSHRC), the Saudi Food and Drug Authority (SFDA) has approved the registration of the first-of-its-kind clinical study (Phase I) of an investigational gene therapy, developed in Saudi Arabia, using Chimeric Antigen Receptor T-cells (CAR T-cells), under the title: “Phase I Study of Chimeric Antigen Receptor (CAR) T-cells in Adult Patients with Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia (ALL), Using a Closed Transduction System.” Acute Lymphoblastic Leukemia (ALL) is a rapidly progressing cancer of the blood and bone marrow that affects lymphoid white blood cells. It causes the bone marrow to produce large number of immature lymphoblasts, which crowd out normal cells and impair the body’s ability to fight infections, transport oxygen, and control bleeding. The investigational treatment is being developed by a team of scientists and researchers at KFSHRC, in collaboration with Lentigen/Miltenyi Company, and manufactured at the hospital within an internal unit that uses a closed transduction system. The treatment is administered to patients through intravenous infusion. The study's primary aim is to confirm the product's safety in adult patients aged 18 to 60 years. The SFDA affirms that this approval is part of its...

 The U.S. Food and Drug Administration has approved updated COVID-19 vaccines for all people aged 65 and older and for people under 65 with higher health risks, the U.S. health secretary said on Wednesday. The U.S. Department of Health and Human Services did not immediately respond to a Reuters request for comment. The three approved shots are made by Pfizer (PFE.N), opens new tab with German partner BioNTech (22UAy.DE), opens new tab, Moderna (MRNA.O), opens new tab, and Novavax (NVAX.O), opens new tab. Pfizer said the emergency use authorization for its COVID vaccine for children under age 5 had been rescinded. Moderna's shot was approved for ages 6 months and up, Health Secretary Robert F. Kennedy Jr. said. Moderna was not immediately available for comment. Pfizer and BioNTech's updated version of Comirnaty was approved for everyone 65 and over, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID infection, the company said in a press release.

The Saudi Food and Drug Authority (SFDA) has approved the registration of Tzield (teplizumab) to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes (T1D). First Treatment to Delay Type 1 Diabetes Tzield is the first drug of its kind to be approved for this medical indication. It is a monoclonal antibody that targets CD3, a cell surface antigen presents on T lymphocytes. By binding to these cells, the product helps to inhibit their activity or decrease their number, which aids in restoring immune balance and delaying disease progression. The product is administered to patients with confirmed Stage 2 T1D, characterized by the presence of at least two positive pancreatic islet autoantibodies and abnormal blood glucose levels, in the absence of type 2 diabetes. It is given as a daily intravenous infusion for 14 consecutive days and is not repeated thereafter. Positive Outcomes in Delaying Disease Progression The SFDA approved Tzield following a comprehensive assessment of the totality of evidence, including its efficacy, safety, and quality, in line with the applicable regulatory standards. Clinical trial data demonstrated that Tzield significantly delayed the onset of stage 3 type 1...

The U.S. Food and Drug Administration on Thursday approved Ionis Pharmaceuticals' drug to prevent instances of severe swelling in various parts of the body of patients with a rare genetic disorder. Shares of the company were up 1.1% in afternoon trading. The drug, Dawnzera, is approved as a so-called "prophylaxis" to prevent symptoms of a rare genetic disease called hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older. The condition causes frequent attacks of severe swelling in various parts of the body, including the hands, feet, genitals and face. Dawnzera will be available in the United States in the coming days with a list price of $57,462 per dose, the company said. HAE is estimated to affect about 7,000 patients in the U.S., according to Ionis. The drug, chemically known as donidalorsen, prevents HAE attacks by lowering levels of a protein called prekallikrein (PKK) that drives swelling and inflammation. Dawnzera can be self-administered through an under-the-skin injection once every four or eight weeks. The approval was supported by late-stage study results that showed the drug, dosed once every four weeks, reduced monthly attacks by 81% compared to a placebo over 24 weeks. Current FDA-approved therapies for HAE fall into two groups: prophylaxis to...

-U.S. health officials gave the Food and Drug Administration the power to quickly authorize veterinarians and farmers to treat or prevent infestations of a flesh-eating livestock pest with animal drugs that may be approved for other purposes or available in other countries, the Department of Health and Human Services said on Tuesday. No cases of the New World screwworm have been confirmed in the U.S. for decades. However, the Trump administration and livestock ranchers anticipate infestations that could reduce the nation's cattle herd and lift beef prices, already at record highs. Screwworm, a parasitic fly that eats livestock and wildlife alive, can infest any warm-blooded animal. Last month, the pest was found in Mexico about 370 miles from the U.S. border, prompting the U.S. Department of Agriculture to indefinitely halt imports of Mexican cattle. The best method to fight screwworm is by breeding sterile flies that reduce the mating population of wild flies. However, experts say many more sterile flies would be needed beyond the current production capacity to slow screwworm's spread in Latin America. It can take a year or more to build facilities to increase sterile fly output. Cattle ranchers may need quick access to screwworm drugs in the meantime, and there...