Search Results for “FDA” – Page 19 – media

BeiGene’s Brukinsa granted FDA accelerated approval for advanced follicular lymphoma

BeiGene’s Brukinsa (zanubrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat relapsed or refractory follicular lymphoma. The BTK inhibitor has specifically been authorised for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) in adult patients who have received at least two prior lines of systemic therapy. The FDA’s decision was supported by positive results from the mid-stage ROSEWOOD study, which demonstrated an overall response rate of 69% for the Brukinsa combination arm compared to 46% for Gazyva alone. An 18-month duration of response of 69% for the Brukinsa combination was also observed, BeiGene said, adding that safety results were consistent with previous studies of both medicines. Mehrdad Mobasher, chief medical officer, haematology at BeiGene, said: “This accelerated approval of Brukinsa represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the US who have either not ...
- Source: drugdu
- 75
- March 12, 2024
FDA Approves Fresenius Kabi’s Tyenne, a Biosimilar of Actemra for the Treatment of Autoimmune Diseases

Don Tracy, Associate Editor Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis. Fresenius Kabi announced today that the FDA has officially approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Developed with the focus of being more accessible and affordable for patients, Tynne is the first tocilizumab biosimilar to be approved by the FDA for intravenous (IV) and subcutaneous use. This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalilmumab-aacf), a biosimilar to Humira.1 “Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. is a moment of great pride for Fresenius Kabi. ...
- Source: drugdu
- 171
- March 11, 2024
FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma

Davy James Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) plus cisplatin and gemcitabine in the frontline treatment of adults with unresectable or metastatic urothelial carcinoma (UC).1 The regulatory action adds to an array of approved indications for Opdivo, both as a single agent and in combination therapy, including for patients with unresectable or metastatic melanoma; metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; locally advanced or metastatic UC; microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer; and hepatocellular carcinoma.2 “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients ...
- Source: drugdu
- 125
- March 9, 2024
FDA Approves AbbVie’s Juvederm Voluma XC for the Treatment of Moderate to Severe Temple Hollowing

Don Tracy, Associate Editor This marks the first time that a hyaluronic acid dermal filler has received FDA approval for temple hollowing. Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvéderm Voluma XC to treat moderate to severe temple hollowing in adults over 21 years of age. According to the company, the medication has the ability to yield results that last up to 13 months with peak treatment, with approximately 80% of test subjects reporting satisfaction with the outcomes. With this regulatory action, Juvéderm Voluma becomes the first hyaluronic acid (HA) dermal filler indicated for moderate to severe temple hollowing to be approved by the FDA.1 “The approval of Juvéderm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs,” said Carrie Strom, president, Allergan Aesthetics, SVP, AbbVie, in a press release. “This is the first US FDA approval of ...
- Source: drugdu
- 122
- March 7, 2024
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
- Source: drugdu
- 134
- March 7, 2024
FDA Clears First Over-the-Counter Continuous Glucose Monitor

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable ...
- Source: drugdu
- 85
- March 7, 2024
FDA Clears Quoin Pharmaceuticals to Employ Teens for Netherton Syndrome Clinical Trials

Don Tracy, Associate Editor Teens to be included in both placebo and open label studies for QRX003, a potential treatment for Netherton syndrome. Today, Quoin Pharmaceuticals announced that the FDA has given approval to include teenagers aged 14 years and older in two ongoing clinical trials for QRX003, a potential treatment for Netherton syndrome (NS). According to a press release, this marks the first time that teen patients with NS will have the opportunity to participate in clinical trials under an Investigational New Drug Application (IND). Additionally, the studies will accommodate teens currently on off-label systemic therapy, with the focus of generating comprehensive data for QRX003’s development.1 “We are very pleased to announce this exciting development, not just for Quoin’s clinical program, but for the Netherton community as a whole,” said Michael Myers, BSc, PhD, CEO, Quoin, in a press release. “We are frequently petitioned by parents and caregivers that ...
- Source: drugdu
- 111
- March 6, 2024
FDA director signals accelerated approval of gene therapy becoming normal! Multiple gene therapies are expected to be launched this year

“If we don’t move toward accelerated approval, many patients will not be able to receive treatment in a timely manner. For many initial approvals of gene therapies, accelerated approval will become the standard process.” Peter Marks said at a seminar held by the Reagan-Udall Foundation in Washington last week . There are currently more than 10,000 rare diseases, but companies often struggle to bring treatments for these diseases to market due to small patient populations and financial constraints. Accelerated approval is a tool that can advance the development of innovative treatments and ensure that companies do not abandon promising treatments. Peter Marks said: “There are many gene therapies for rare diseases that are almost successful. The key question now is, how do we push them to the finish line smoothly?” For gene therapy for rare diseases, a balance between supervision and science is needed. How to supervise gene therapy more ...
- Source: drugdu
- 130
- March 6, 2024
Nuvalent Granted FDA Breakthrough Therapy Designation for Non–Small Cell Lung Cancer Drug

February 28, 2024 Davy James NVL-520 is a novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor under evaluation for patients with metastatic ROS1-positive non–small cell lung cancer. Nuvalent, Inc’s novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor (TKI) NVL-520 has been granted Breakthrough Therapy Designation by the FDA to treat patients with metastatic ROS1-positive non–small cell lung cancer (NSCLC) who received prior therapy with at least two ROS1 TKIs.1 NVL-520 was developed with the intention of addressing treatment challenges that limit the use of current ROS1 TKIs, including treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events (AEs) that have been linked to inhibiting the structurally-related tropomyosin receptor kinase family.1 “In line with our commitment to bringing new potential best-in-class medicines to patients with cancer as quickly as possible, we are always looking for opportunities to further accelerate our programs,” James Porter, PhD, CEO of Nuvalent, said in a press release. ...
- Source: drugdu
- 91
- March 2, 2024
FDA Issues Refusal to File Letter to Theratechnologies for sBLA Seeking Approval of Intramuscular Administration of Trogarzo

Davy James Trogarzo (ibalizumab-uiyk) is currently approved in combination with other antiretroviral therapy for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen. The FDA has issued a refusal to file letter (RTF) to a supplemental Biologics License Application (sBLA) filed by Theratechnologies Inc. for an intramuscular (IM) method of administration for maintenance dosing of Trogarzo (ibalizumab-uiyk).1 The CD4-directed post-attachment HIV-1 inhibitor is approved in combination with other antiretroviral therapy (ART) for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current ART regimen.2 The RTF followed a preliminary review of the sBLA by the FDA, which found that the application did not include data the agency required to establish a pharmacokinetic bridge between IM administration and intravenous (IV) administration of Trogarzo. “While we are disappointed to receive this letter from the FDA, we were aware that the approval of this ...
- Source: drugdu
- 112
- March 2, 2024

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