Search Results for “FDA” – Page 15 – media

Enhertu Gets FDA Accelerated Approval for Unresectable, Metastatic HER2-Positive Solid Tumors

Davy James The approval of AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug’s approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. The FDA has granted accelerated approval to AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive, immunohistochemistry (IHC) 3+ solid tumors who were previously administered systemic therapy and who have no satisfactory alternative treatment options.1 The regulatory action for the HER2-directed antibody-drug conjugate (ADC) adds to Enhertu’s approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction adenocarcinoma. “As the first antibody drug conjugate to be granted a tumor-agnostic indication, Enhertu is truly delivering on its potential across metastatic HER2-targetable tumors,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, in a press release. “This approval also ...
- Source: drugdu
- 128
- April 10, 2024
FDA Approves Abecma for Patients with Relapsed or Refractory Multiple Myeloma Following Two Prior Lines of Therapy

Davy James Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy. The FDA has approved Bristol Myers Squibb’s and 2seventy bio’s Abecma (idecabtagene vicleucel) to treat adults with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy that included an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.1 The regulatory action expands the indication for Abecma to earlier lines of treatment in patients whose disease relapsed or became refractory following administration of the three primary treatment classes following two prior lines of therapy. “Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the ...
- Source: drugdu
- 84
- April 9, 2024
Beckman Coulter receives FDA warning letter

Dive Brief Beckman Coulter received a warning letter in March after inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests. The Food and Drug Administration, which published the letter Tuesday, said Beckman failed to adequately establish procedures for risk analysis and other activities at a facility in Minnesota. Beckman Coulter responded to the observations in January and February 2024, but the FDA said the responses to specific problems were either inadequate or impossible to assess at this time. Dive Insight The warning letter names the DxI 9000 Access Immunoassay analyzer instrument system and assays as the device that is “adulterated” because of the compliance failings. Rainer Blair, CEO of Beckman’s parent company Danaher, singled out Dxl 9000 as a new product that is “enabling faster, more accurate patient diagnosis” on an earnings call in January. Beckman was a growth driver in the fourth ...
- Source: drugdu
- 86
- April 8, 2024
RemeGen’s Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren’s Syndrome

YANTAI, China, April 3, 2024 /PRNewswire/ — RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, 688331.SH), a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) recently for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18), independently developed by RemeGen for the treatment of patients with primary Sjögren’s syndrome (pSS). The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs. Primary Sjögren’s syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage with multiple organ systems also at risk of being affected. Studies have shown that B-cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B-cells is a pathogenic indicator ...
- Source: drugdu
- 129
- April 8, 2024
Baxter receives FDA clearance for delayed Novum IQ infusion pump

Dive Brief Baxter has received 510(k) clearance for its large volume infusion pump (LVP) Novum IQ, the company said Monday. The clearance follows three years of talks with the Food and Drug Administration, in which time a delay to the authorization drove Baxter to wipe $100 million in sales off its forecast in 2022. A Baxter spokesperson said in an email that the company will update 2024 guidance on its upcoming first-quarter earnings call and expects Novum IQ to be a meaningful contributor to future growth. Evercore ISI analysts said the success of Baxter’s Spectrum pumps and the return of BD’s Alaris to the market means the $100 million annual sales assumption no longer applies. Even so, Evercore and Stifel analysts called the clearance positive for Baxter in notes to investors. Dive Insight The FDA identified an issue with Baxter’s filing for clearance of the LVP version of Novum IQ ...
- Source: drugdu
- 139
- April 5, 2024
Abbott nets FDA approval for Triclip

Dive Brief Abbott said Tuesday it received the Food and Drug Administration’s approval to market a transcatheter device for repairing the tricuspid valve in patients who are unable to withstand open-heart surgery. The go-ahead from the FDA paves the way for Abbott’s Triclip repair system to compete in the U.S. against Edwards Lifesciences’ recently approved transcatheter tricuspid valve replacement device, Evoque. Triclip uses the same clip-based technology to treat tricuspid regurgitation as Abbott’s Mitraclip for mitral valve regurgitation, a device the company has credited with driving double-digit growth in its structural heart business. Dive Insight Valve regurgitation, or leaking, occurs when the heart valve does not close correctly as it opens and shuts to circulate blood. The tricuspid valve controls blood flow from the right atrium to the right ventricle. When the valve isn’t closing properly, blood can flow backward in the heart, forcing it to work harder. Most common ...
- Source: drugdu
- 137
- April 5, 2024
FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside

Don Tracy, Associate Editor The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says. The FDA has approved Abbott’s i-STAT TBI cartridge to use with whole blood for rapid bedside assessment of patients with suspected concussions. The company stated this regulatory action is significant because previously available concussion tests required plasma or serum and lab processing. The device has been found to provide lab-quality results in 15 minutes to evaluate patients over the age of 18 years up to 24 hours after injury. Abbott stated the approval is an important milestone, citing that many individuals may have to wait following an injury to obtain proper treatment for the symptoms of a concussion.1 “Emergency departments can be a busy place. It’s important to be able to triage patients quickly,” Geoffrey Manley, MD, PhD, chief, neurosurgery, Zuckerberg San Francisco General Hospital, ...
- Source: drugdu
- 108
- April 5, 2024
FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. By FRANK VINLUAN A software app that modifies behavior through a series of lessons and exercises has received FDA clearance for treating patients with major depressive disorder, making it the first prescription digital therapeutic for this indication. The product, known as CT-152 during its development by partners Otsuka Pharmaceutical and Click Therapeutics, will be commercialized under the brand name Rejoyn. Rejoyn is an alternative way to offer cognitive behavioral therapy, a type of talk therapy in which a patient works with a clinician in a series of in-person sessions. In Rejoyn, the cognitive behavioral therapy lessons, exercises, and reminders are digitized. The treatment is intended for use ...
- Source: drugdu
- 122
- April 4, 2024
FDA Approves Alexion’s Voydeya as Add-on Treatment for Adults with Extravascular Hemolysis

Don Tracy, Associate Editor Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis. Alexion, AstraZeneca Rare Disease announced that the FDA has approved Voydeya (danicopan) as an add-on therapy for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH), in combination with ravulizumab or eculizumab. According to the company, the medication treats patients with significant EVH despite receiving C5 inhibitor therapy. The approval was based on positive results from the Phase III ALPHA trial, which found that Voydeya improved hemoglobin levels while providing the benefit of avoiding transfusions after a primary 12-week period. Additionally, there was no significant increases reported related to safety concerns, with common adverse reactions including headache, nausea, arthralgia, and diarrhea.1 “The approval of first-in-class, Factor D inhibitor Voydeya marks an important advancement in the treatment of PNH and builds on ...
- Source: drugdu
- 89
- April 4, 2024
Alexion’s Voydeya gains FDA approval for extravascular haemolysis

Alexion, AstraZeneca Rare Disease has received approval from the US Food and Drug Administration (FDA) for Voydeya (danicopan) as an add-on therapy to treat extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). A first-in-class, oral Factor D inhibitor, Voydeya has been developed for patients who continue to suffer from EVH despite treatment with C5 inhibitors such as Ultomiris (ravulizumab) or Soliris (eculizumab). The FDA’s decision is grounded in the positive outcomes of the ALPHA Phase III trial, which demonstrated that Voydeya met its primary endpoint of haemoglobin change from baseline to week 12, alongside all key secondary endpoints. The drug was generally well-tolerated with no new safety concerns. As part of the ALPHA double-blind, placebo-controlled, multiple-dose trial, patients were enrolled and randomised to receive Voydeya or placebo apart from their ongoing Soliris or Ultomiris therapy over 12 weeks. It aimed to assess the superiority of Voydeya as an ...
- Source: drugdu
- 128
- April 4, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.