Search Results for “FDA” – Page 10 – media

Insmed’s Trial Results Pave Way for FDA Filing in a Lung Disease With No Approved Therapies

Brensocatib, a drug Insmed licensed from AstraZeneca, met the main goal of a Phase 3 test in non-cystic fibrosis bronchiectasis. Insmed plans to seek regulatory approvals in this indication while also continuing to develop the small molecule for other inflammatory disorders. By Frank VinluanAn Insmed drug developed for a serious chronic lung disorder with no FDA-approved therapies handily beat a placebo in a pivotal clinical trial, preliminary results that set the stage for a regulatory submission planned for later this year. It could be the first of several. The drug is also in development for other inflammatory conditions, giving the drug multiple opportunities to achieve its blockbuster potential. The first disease target of the Insmed drug is non-cystic fibrosis bronchiectasis (NCFB), a chronic lung disease characterized by excess production of sputum that’s persistently coughed up from the respiratory tract. Patients who have NCFB also experience frequent respiratory infections. There’s no ...
- Source: drugdu
- 98
- May 30, 2024
FDA Grants Fast Track Designation to AV-001 for Moderate-to-Severe Acute Respiratory Distress Syndrome

Don Tracy, Associate Editor Fast track designation for AV-001 comes amid promising results from a Phase I trial, which supported once-daily dosing and effective Tie2 activation. Vasomune Therapeutics announced that the FDA has granted Fast Track designation to AV-001, an investigational drug in development to prevent or treat moderate-to-severe acute respiratory distress syndrome (ARDS) in patients with respiratory infections. According to the company, Phase I data demonstrated the safety and pharmacokinetic profile of AV-001, backing once-daily dosing. Additionally, the treatment showed support for strong Tie2 activation. AV-001 is currently recruiting patients for a Phase IIa trial as an ARDS treatment in pneumonia.1 “Vasomune is focused on the persisting unmet needs of people grappling with ARDS and other diseases driven by vascular endothelial instability,” said Brian Jahns, PharmD, president, chief operating officer, Vasomune Therapeutics, in a press release. “Vasomune is indebted to the United States Department of Defense Congressionally Directed Medical ...
- Source: drugdu
- 93
- May 30, 2024
Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL

Sucralfate is used to treat stomach ulcers,GERD, radiation proctitis, and stomach inflammation and to prevent stress ulcers. Strides Pharma Science (Strides) recently announced that its stepdown wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for the generic version of Sucralfate Oral Suspension, 1gm/10 mL, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate 1gm/10mL of AbbVie. Sucralfate is used to treat stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, and stomach inflammation and to prevent stress ulcers. Sucralfate Oral Suspension, 1gm/10 mL has a market size of ~US$ 124Mn as per IQVIA (March 2024). The Sucralfate Oral Suspension, 1gm/10 mL will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India. https://www.expresspharma.in/strides-receives-usfda-approval-for-sucralfate-oral-suspension-1gm-10-ml
- Source: drugdu
- 122
- May 25, 2024
Durect’s Larsucosterol Receives FDA Breakthrough Therapy Designation for Severe Alcohol-Associated Hepatitis

Don Tracy, Associate Editor Moving forward, Durect plans on incorporating feedback from the FDA in the design of a Phase III trial. DURECT Corporation announced that the FDA has granted Breakthrough Therapy Designation (BTD) to larsucosterol, a medication that aims to treat patients with severe alcohol-associated hepatitis (AH). According to the company, the designation is based on positive results from the Phase IIb AHFIRM trial, which demonstrated positive safety and efficacy outcomes, with the first portion of data being announced last year, while additional clinical data is expected to be presented at the. European Association for the Study of the Liver (EASL) Congress next month.1 “We’re pleased with the FDA’s decision to grant Breakthrough Therapy designation to larsucosterol, as it further recognizes its potential to save the lives of AH patients,” said James E. Brown, DVM, President, CEO, DURECT, in a press release. “AH has a high mortality rate and ...
- Source: drugdu
- 77
- May 24, 2024
FDA Approves Biocon Biologics’ Yesafili, an Eylea Biosimilar, for the Treatment of Multiple Ophthalmic Conditions

Don Tracy, Associate Editor Approval of Yesafili represents Biocon’s entrance into the US ophthalmology market, following previous approvals in Europe and the UK. Biocon Biologics announced that it has received FDA approval for Yesafili (aflibercept-jbvf), a biosimilar to Eylea (aflibercept). According to the company, Yesafili is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of several ophthalmic conditions such as neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). Prior to being approved by the FDA, Yesafili was cleared in the United Kingdom back in November, while European approval came in September. Additionally, it is expected to launch in Canada by July 1, 2025.1 “The FDA approval of Yesafili (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into ophthalmology, a new therapeutic ...
- Source: drugdu
- 84
- May 23, 2024
FDA Grants Accelerated Approval to Amgen’s Imdelltra for the Treatment of Adults with Extensive-Stage Small Cell Lung Cancer

Don Tracy, Associate Editor Imdelltra (tarlatamab-dlle) is the first T-cell engager therapy approved for extensive stage small cell lung cancer. The FDA has granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following treatment with platinum-based chemotherapy. According to the company, the regulatory action was based on the promising response rate and duration of response (DoR) with Imdelltra observed in clinical studies. The action represents the first and only T-cell engager therapy approved by the FDA for ES-SLCS, and Amgen stated that further indications for the use of Imdelltra could soon follow.1 “The FDA’s approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients,” said Jay Bradner, MD, EVP, research and development, chief scientific officer, Amgen, in a press release. “This ...
- Source: drugdu
- 81
- May 21, 2024
USFDA concludes inspection of Indoco’s Rabale facility

Indoco Remedies announced that the United States Food and Drug Administration (USFDA) successfully completed inspection of its API Kilo Lab manufacturing facility at Rabale, Navi Mumbai and Indoco Analytical Solutions (IAS) division. The inspection concluded with zero Form 483 observations. “We remain committed to ensuring the safety and efficacy of our products while maintaining the trust of our customers and stakeholders”, said Aditi Panandikar, MD, Indoco Remedies. https://www.expresspharma.in/usfda-concludes-inspection-of-indocos-rabale-facility/
- Source: drugdu
- 103
- May 20, 2024
FDA Approves Roche’s HPV Self-Collection Solution, Allowing Patients to Gather Their Own Samples in a Healthcare Setting

Don Tracy, Associate Editor Roche’s human papillomavirus solution is reportedly one of the first of its kind to be available in the United States. Roche announced that the FDA has approved its human papillomavirus(HPV) self-collection solution, one of the first of its kind approved in the United States. According to the company, the new tool allows individuals to collect their own samples in a healthcare setting for HPV testing, supporting early detection and prevention of cervical cancer. Analyzed through Roche’s Cobas molecule instrument, positive results require follow-up care with a healthcare provider. Roche’s fully automated Cobas 5800/6800/8800 Systems can provide up to 96 results in approximately three hours, 384 results for the Cobas 6800 System, and 1,056 results for the Cobas 8800 System in eight hours.1 “With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach,” said Matt Sause, ...
- Source: drugdu
- 81
- May 17, 2024
FDA Grants Priority Review Biologics License Application to Dupixent Add-On Maintenance for the Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis

Don Tracy, Associate Editor Dupixent has previously been approved for adults with chronic rhinosinusitis with nasal polyposis whose condition is inadequately controlled. Regeneron and Sanofi announced that the FDA has granted Priority Review to their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years who have chronic rhinosinusitis with nasal polyposis (CRSwNP) and whose condition is inadequately controlled. With the treatment already approved for adults with CRSwNP, the FDA is expected to make a final decision on the sBLA for the expanded indication by September 15, 2024.1 According to the companies, the application is supported by efficacy data from SINUS-24 and SINUS-52, two trials that showed major improvements in nasal congestion/obstruction severity, nasal polyp size, sense of smell, and a reduction in the need for systemic corticosteroids or surgery. In 2019, Regeneron first released the results of both trials, ...
- Source: drugdu
- 83
- May 15, 2024
FDA posts final guidance on remanufacturing medical devices

Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
- Source: drugdu
- 102
- May 13, 2024

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