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From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. Date of FDAapproval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19.
The dual FLT-3 and Aurora kinase inhibitor EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance. Ellipses Pharma stated that the dual FLT3 inhibition and Aurora kinase demonstrated to overcome the acquired resistance to selectively inhibit FLT3 in vitro and in vivo.
Shorla Oncology has received US Food and Drug Administration (FDA) approval for Imkeldi, an oral solution of imatinib designed to treat specific forms of leukemia and other cancers. These cancers affect thousands of patients annually in the US, making Imkeldi’s approval a meaningful step forward in addressing unmet treatment needs.
Medical device and in vitro diagnostics technologies provider SurModic Inc. has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). The balloon is designed for the treatment of patients with peripheral artery disease.
Gilead’s Veklury (remdesivir) gets FDAapproval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12. This is the only approved COVID-19 treatment for children under 12 years of age. SARS-CoV-2 is known to affect people of all ages.
Maculus plans to raise USD3 million on a USD8 million valuation for a 12-18 month period, including initial in-vivo animal studies and completion of in-vitro / in-vivo drug elution studies. Capable of delivering any FDAapproved.
After securing FDAapproval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Central nervous system-controlled behaviour, such as food intake, is notoriously difficult to explore in vitro.
Roche’s Executive Vice President, Chief Medical Officer, Head of Global Product Development and Co-Founder of Foundation Medicine Inc. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes.
Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.
Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. Single- and multi-nation funding opportunities flooded in.
a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. California-based Tarsus Pharmaceuticals Inc., What Is Demodex Blepharitis?
FDAApproves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)–Oct.
This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. months, not reached). 2 The most common adverse reactions (?
SK Chemicals has shared their expertise in these diseases and validated the predicted targets and compounds through in vitro and in vivo studies. Further research on and development of the compound is ongoing with the objective of completing preclinical studies. About Standigm. Standigm is an AI-driven drug discovery company.
Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”
The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Jude Children’s Research Hospital.
Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S.
There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. The hard problem: innovation for high prevalence, chronic diseases of ageing.
Its purpose is to stimulate the development of new drugs for rare pediatric diseases by offering additional incentives for obtaining FDAapproval of such products beyond the incentives offered by the ODD program. The FDA must deem the application eligible for priority review (i.e., Criteria to Obtain the Designation.
The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). About 80 percent of acute cases are asymptomatic.
Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021.
These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. 1) Medtronic 2022 Revenue: Medtronic reported an annual revenue of $31.69
billion Company: Pfizer Disease it is FDA-approved to treat: Comirnaty is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. billion in sales in 2022.
Brain Awareness Week 2024 , taking place March 11 to 17 this year, is a global campaign that aims to demystify the complexities of the human brain and promote the significance of neuroscientific research. This relates to neurological conditions like dementia and Alzheimer’s disease, which account for up to 70 percent of dementia cases.
Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S. The FDAapproval of Klisyri is a significant milestone for Athenex,” said Johnson Lau, chairman and chief executive officer of Athenex. The FDA completed a class 2 response in July 2020.
If approved, Actemra/RoActemra would be the first U.S. FDAapproval is expected in the second half of this year. Chief Medical Officer and Head of Global Product Development, Roche. “The Chief Medical Officer and Head of Global Product Development, Roche. A decision on U.S. Actemra/RoActemra is not U.S.
The US Food and Drug Administration (FDA) has approved Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma who have specific HLA types and have undergone prior chemotherapy. It is also the first new treatment for adults with synovial sarcoma in over a decade.
Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). At various points and in various ways, FDA has sought – mostly unsuccessfully – to regulate LDTs (see here ).
Through the utilization of their state-of-the-art technology and substantial investments in research and development (R&D), these med tech/medical device companies persist in driving industry innovation beyond the pandemic, thereby laying the foundation for a more streamlined approach against diseases in the future.
Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. This test, which is being co-developed with Eli Lilly, has the potential to facilitate earlier and more accurate detection of the disease.
In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., It is important to note that these studies are required by U.S. and around the world.
Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.
Supports the Development of New Approaches to Treat Multiple Neurological Diseases.
Ichtchenko developed and tested a potential treatment for botulism based on intracellular inhibition of the BoNT subtype A1 light chain metalloprotease (LC/A1).
NEW YORK, Jan. 07, 2021 (GLOBE NEWSWIRE) — CytoDel, Inc.
Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD).
OCREVUS is the first and only treatment approved for both relapsing MS (RMS) and primary progressive MS (PPMS) and now more than 170,000 people have been treated with OCREVUS globally in clinical trial and real-world settings; favourable benefit-risk profile remains consistent over 7 years. Separate data from a U.S.
Roche’s Chief Medical Officer and Head of Global Product Development. “We Roche’s Chief Medical Officer and Head of Global Product Development. “In Phase IIIb clinical trial programme of higher-dose OCREVUS (ocrelizumab) to evaluate impact on reducing disability progression in RMS and PPMS.
Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed. They are also designed to have a short in vitro half-life, meaning that they will be cleared from a patient’s system within several hours.
Roche’s Chief Medical Officer and Head of Global Product Development. “I Roche’s Chief Medical Officer and Head of Global Product Development. Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS. “I
With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. They are different from small molecules in terms of their size and complexity.
The identification of T cells that essentially ‘hide’ the virus has significant implications for developing therapeutic strategies to improve the treatment and long-term management of HIV. Related: FDAApproves Rukobia for HIV Patients with Limited Treatment Options. The research study was published in Cell Reports.
Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to expand the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat cystic fibrosis (CF) in children aged between two and five years with certain mutations.
The company has also filed for the US Food and Drug Administration (FDA) for clearance. According to DelveInsight’s analysis , the approval of RETINA-AI Galaxy software will be a game-changer in the annual examination of the eye in diabetic patients. developer of the WOLF Thrombectomy® Platform. Dr. Stephen G.
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