Search Results for “FDA” – Page 34 – media

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
- 94
- 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
- 133
- 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
- 97
- 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
- 100
- 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
- 220
- November 3, 2023
FDA Grants Fast Track Designation to Sellas Life Sciences’ SLS009 for Lymphoma

Don Tracy, Associate Editor SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas. Sellas Life Sciences announced that the FDA has granted Fast Track Designation to SLS009, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). The designation intends to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.1 “The FDA’s decision to grant SLS009 Fast Track designation signifies an important milestone towards developing a safe and effective treatment for PTCL, a group of aggressive and rare non-Hodgkin lymphomas, and underscores the urgent need for innovative therapies such as SLS009 that can significantly improve the outcome of PTCL patients,” said Angelos Stergiou, MD, ScD hc, president, CEO, Sellas, in a company press release. “SLS009 has demonstrated very promising clinical responses in PTCL patients in the recently completed ...
- Source: drugdu
- 105
- November 3, 2023
Amgen scores FDA approval for Stelara biosimilar

Amgen’s interchangeable biosimilar version of Johnson & Johnson’s (J&J) Stelara, dubbed Wezlana (ustekinumab-auub), has received an US Food and Drug Administration (FDA) approval. The interchangeable biosimilar was approved for use in multiple inflammatory diseases, including for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderate to severe active ulcerative colitis. The agency approved Wezlana after a comprehensive review of scientific evidence, which showed that Wezlana was highly similar to ustekinumab and there were no clinically meaningful differences between the products in regard to safety, purity, and potency. Stelara was first approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis in September 2009. The FDA later approved the IL-12/IL-23 inhibitor’s use in moderate to severe Crohn’s disease in November 2016, and later for active psoriatic arthritis and ulcerative colitis. ...
- Source: drugdu
- 99
- November 3, 2023
Merck’s Keytruda nabs FDA nod in biliary tract cancer, catching up with AstraZeneca’s Imfinzi

After AstraZeneca’s Imfinzi last year claimed new territory in the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. The approval in locally advanced unresectable or metastatic biliary tract cancer, combined with the chemotherapies gemcitabine and cisplatin, marks Keytruda’s sixth U.S. nod in gastrointestinal cancer, Merck said. The FDA based the approval on data from the company’s Phase 3 KEYNOTE-966 trial, which showed that the Keytruda-chemo combo extended patients’ survival time compared with chemotherapy alone. In the study, patients in the treatment arm lived a median 12.7 months, compared to 10.9 months for those on solo chemo. The Keytruda-chemo combo reduced the risk of death by 17% over solo chemotherapy, researchers found. In addition, Keytruda-treated patients experienced a longer median duration of response at 9.7 months, compared with 6.9 months for solo chemotherapy. Merck is “proud” to offer the new treatment ...
- Source: drugdu
- 101
- November 3, 2023
FDA posts updated safety data on Bayer’s Essure, notes progress on improving study

Dive Brief A postmarket surveillance study has linked Bayer’s Essure birth-control implant to a numerically higher rate of some safety outcomes than laparoscopic tubal sterilization (LTS). The latest interim analysis of the study, which the Food and Drug Administration asked Bayer to run, shows trends seen in previous years persisted. Rates of gynecologic surgical procedures and endometrial ablation were numerically higher in the Essure group. Bayer has acted on the FDA’s request for actions to improve follow-up rates in the study, leading the administration to remove the “inadequate” progress tag it applied to the trial last year. Dive Insight The origins of the postmarket surveillance study date back to 2016, when the FDA asked Bayer to collect data on the device. Bayer stopped selling the device in the U.S. two years later, framing the action as a business decision rather than a reflection of the safety of a product that ...
- Source: drugdu
- 116
- November 2, 2023
FDA approves UCB’s inflammatory disease drug Bimzelx for plaque psoriasis

The US Food and Drug Administration (FDA) has approved UCB’s inflammatory disease drug to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.The decision makes Bimzelx (bimekizumab-bkzx) the first and only approved psoriasis treatment designed to selectively inhibit IL-17A and IL-17F, two key cytokines driving inflammatory processes. More than 7.5 million adults in the US are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales. The plaques may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back. As well as its physical manifestations, psychological impact has been increasingly recognised as a significant part of ...
- Source: drugdu
- 137
- October 20, 2023

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