Search Results for “FDA” – Page 33 – media

FDA Approves Takeda’s Treatment for Rare Blood Clotting Disorder

Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura. The FDA has approved Takeda’s Adzynma as the first genetically engineered protein medication for the preventative treatment or for on-demand enzyme replacement therapy in patients with congenital thrombotic thrombocytopenic purpura (cTTP). Image credit: olegganko | stock.adobe.com The FDA granted the application for Adzynma with a Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations. cTTP affects fewer than 1,000 individuals in the United States. “The FDA remains deeply committed in our efforts to help facilitate the development and approval of safe and effective therapies for patients with rare diseases,” said FDA Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, in a press release.1 “Without treatment, cTTP is ultimately fatal. Today’s approval reflects important progress in the development of ...
- Source: drugdu
- 98
- November 13, 2023
Eli Lilly’s tirzepatide injection approved by MHRA and FDA for weight loss in adults

Eli Lilly’s tirzepatide injection has been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) for weight loss and weight management in individuals aged 18 years and over. Both regulators have authorised the dual GIP/GLP-1 agonist, sold under the brand name Mounjaro or Zepbound, for use alongside a reduced-calorie diet and increased physical activity in adults with a BMI of 30 or more, as well as those with a BMI of 27 or more and at least one weight-related health problem such as pre-diabetes, high blood pressure or high cholesterol. Tirzepatide, which is currently used to treat type 2 diabetes, will be available for weight management as a pre-filled pen to be injected under the skin of a patient’s stomach area, thigh or upper arm. The new indications are supported by the results of two late-stage trials, which demonstrated that obese ...
- Source: drugdu
- 101
- November 13, 2023
With FDA approval, Eli Lilly’s weight-loss drug Zepbound arrives to challenge Novo Nordisk

In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday, the Indianapolis-based company scored FDA approval for its GIP/GLP-1 compound tirzepatide to treat obesity, which will allow broader access to the treatment in the U.S. Dubbed Zepbound, Lilly’s new product is the same formula as blockbuster Type 2 diabetes drug Mounjaro. Since it was endorsed by the FDA in May 2022, Mounjaro has gained widespread, off-label use to treat obesity. Now, Zepbound has been indicated for adults with a BMI of 30 or higher as well as those with a BMI of 27 or higher with weight-related problems such as hypertension, Type 2 diabetes, sleep apnea or cardiovascular disease. With the FDA nod, Lilly now has its answer to Novo’s blockbuster duo of Ozempic for diabetes and Wegovy for obesity. The Danish company gained FDA green lights ...
- Source: drugdu
- 100
- November 10, 2023
Janssen Sends Data for Phase III Children’s Pulmonary Tuberculosis Treatment to FDA and EMA

Don Tracy, Associate Editor Company aims to receive approval on a Type II Variation application for Sirturo for patients with pulmonary tuberculosis. The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for bedaquiline (Sirturo), indicated as part of a combination therapy for adults and pediatric patients over the age of five with pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis. Back in August, a supplemental New Drug Application (sNDA) was also submitted to the FDA for the medication. According to data from the CDC, there was a report of approximately 8,300 cases of TB in 2022, up from 7,874 cases reported in 2021. The center also reports that TB cases in the United States are beginning to return to pre-pandemic levels, following a substantial decline in 2020, likely due to factors associated with ...
- Source: drugdu
- 131
- November 10, 2023
FDA Approves Eli Lilly Weight Drug, Now Set to Compete Against Novo’s Wegovy

Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less. By FRANK VINLUAN A blockbuster Eli Lilly drug for type 2 diabetes now has an additional FDA approval in chronic weight management, a regulatory decision that positions the pharmaceutical giant to more directly compete in cardiometabolic conditions against a Novo Nordisk molecule that has become a sales juggernaut in its own right. Lilly’s new drug is the same as its type 2 medication Mounjaro, but it will be marketed under the brand name Zepbound. The Indianapolis-based drugmaker expects Zepbound will become available in the U.S. by the end of this year. The FDA approved Zepbound as a way to help patients lose weight and keep it off. The Wednesday regulatory decision ...
- Source: drugdu
- 101
- November 10, 2023
FDA warns of hidden drug ingredients in Dr Ergin’s SugarMD

The US Food and Drug Administration (FDA) has issued a warning against the use of the glucose management product, Dr Ergin’s SugarMD Advanced Glucose Support. The regulator asked consumers not to buy and to immediately stop using the product, promoted and sold for blood glucose management due to hidden drug ingredients. Several SugarMD products are sold online on Amazon as supplements for those with type 1 and type 2 diabetes. One of the supplements, GlucoDefense to maintain glucose metabolism is advertised to produce “truly remarkable [results] within just 6 weeks”. In laboratory tests carried out by the FDA, active ingredients glyburide and metformin were confirmed to be present in the drug. Glyburide and metformin are in several FDA drugs used to treat type-2 diabetes that can only be obtained with a prescription. Both of these ingredients can pose a serious risk to consumers. Glyburide can result in unsafe drops in ...
- Source: drugdu
- 91
- November 9, 2023
FDA extends pandemic-era policy allowing certain device, production changes without prior approval

Dive Brief The Food and Drug Administration will continue to allow medical device manufacturers to make alterations to certain products or manufacturing processes without prior authorization if the changes are due to production limitations or supply chain challenges. The policy is a continuation of COVID-19 pandemic-era changes that eased some requirements on device makers during the crisis. The guidance document, issued Thursday, outlines examples of when companies would not be required to file a premarket application (PMA) or humanitarian device exemption (HDE) supplement, or a 30-day notice, before making changes. While the policy was initially created for the emergency pandemic environment, the FDA wrote in the guidance document that it has “continued to observe supply chain challenges and shortages of medical devices remain widespread.” The agency removed the policy’s expiration date, but it could make revisions in the future. Dive Insight The guidance, first issued in May 2020, was supposed ...
- Source: drugdu
- 131
- November 5, 2023
Merck’s Keytruda combination granted FDA approval for biliary tract cancer

Merck & Co – known as MSD outside the US and Canada – has announced that the US Food and Drug Administration (FDA) has approved its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with chemotherapy to treat biliary tract cancer (BTC). The approval, which represents the sixth gastrointestinal cancer indication for Keytruda-based regimens in the US, means Keytruda can now be used alongside gemcitabine and cisplatin to treat patients with locally advanced unresectable or metastatic BTC. BTC is a group of rare and highly aggressive cancers in the liver, gallbladder and bile ducts. Approximately 20,000 people are diagnosed with the disease each year in the US and about 70% of BTC patients are diagnosed at an advanced stage. The FDA’s approval was supported by results from the late-stage KEYNOTE-966 trial, which demonstrated a significant overall survival benefit in these patients versus chemotherapy alone. The results showed that the Keytruda regimen reduced ...
- Source: drugdu
- 94
- November 4, 2023
Phathom passes acid tests, capturing 2 FDA approvals for Voquezna after impurity setback

In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna (vonoprazan). The first came Monday when the regulator signed off on Phathom’s reformulation of Voquezna to treat Helicobacter pylori infection. The second came Wednesday when the FDA blessed Voquezna for gastroesophageal reflux disease erosive esophagitis (erosive GERD) and associated heartburn. Two approvals for the same compound in a week is unusual. The FDA originally endorsed Voquezna for H. pylori in May of last year, but then it put Phathom’s launch plans on hold when trace levels of a cancer-causing agent were discovered in commercial batches of the treatment. That initial approval was later revoked. During the impurity-related holdup, the FDA also iced Phathom’s application for approval for erosive GERD. In April, after receiving complete response letters for both applications, Phathom said that it had shown the FDA stability ...
- Source: drugdu
- 97
- November 4, 2023
FDA warning letter accuses Wavi of selling unapproved neurological device

Dive Brief The Food and Drug Administration has sent a warning letter to Wavi, accusing the company of selling an unauthorized device to help diagnose patients with potential neurological conditions. Wavi markets its headset, plus associated devices and software, as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age. The FDA, which sent inspectors to Wavi’s facility in Denver in March, views the technology as a medical device and sent a warning letter because the product lacks premarket approval. Dive Insight In the letter, the FDA states that Wavi promotes and distributes Wavi Desktop, a product that collects, analyzes and interprets electroencephalograph data, event-related potentials and heart rate variability data. The instruction manual “contains evidence that the device is intended to aid in the evaluation of autonomic nervous system function, head injury, depression, attention-deficit/hyperactivity disorder, anxiety, and ...
- Source: drugdu
- 216
- November 3, 2023

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