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Safety Data Articles & Analysis

134 news found

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. These reliable testing solutions will meet the evolving needs of the medical device industry and help manufacturers ...

BySTEMart


AngioDynamics Announces CE Mark Approval in Europe for AlphaVac F1885 System

AngioDynamics Announces CE Mark Approval in Europe for AlphaVac F1885 System

AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced European CE Mark approval of the AlphaVac F1885 System for the non-surgical removal of thrombi or emboli from the pulmonary arteries and for ...

ByAngioDynamics, Inc.


AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism

AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism

AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the completion of patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV). APEX-AV is a ...

ByAngioDynamics, Inc.


Comprehensive Gene Therapy Development Solutions to Further Boost Rare Disease Research

Comprehensive Gene Therapy Development Solutions to Further Boost Rare Disease Research

As several gene therapy approvals for rare disease treatment gain steam in 2023, a comprehensive set of gene therapy development solutions is released to pave richer avenues for rare disease research. This path-breaking move sees the integration of cutting-edge technology with state-of-art research facilities to amplify the possibilities of devising effective remedies for rare diseases. Rare ...

ByProtheragen


Bayer initiates phase III study to investigate aflibercept 8 mg in retinal vein occlusion

Bayer initiates phase III study to investigate aflibercept 8 mg in retinal vein occlusion

Global phase III QUASAR study will assess the efficacy and safety of aflibercept 8 mg in macular edema secondary to retinal vein occlusion (RVO) Study comes after positive data from the phase III PULSAR trial in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON trial in diabetic macular edema (DME) QUASAR is expected to enroll around 800 patients in 27 ...

ByBayer AG


CD Formulation Provides Pharmaceutical Testing on Tablet Fragility, Dissolution, and Disintegration

CD Formulation Provides Pharmaceutical Testing on Tablet Fragility, Dissolution, and Disintegration

Pharmaceutical testing is a must to ensure that all medications meet the top quality, safety, and performance requirements before they enter the market. CD Formulation’s cGMP-compliant laboratory is well-equipped to identify both the chemical and structural composition of each drug substance. More recently, the company announced to broaden its service range to tablet fragility test, ...

ByCD Formulation


Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat. ORSERDU is the first endocrine innovation in more than 20 years, specifically addressing ESR1 mutations, a major unmet need. The Menarini Group (“Menarini”), a ...

ByThe Menarini Group


Galapagos and CellPoint presented encouraging initial data at ASH 2022 for GLPG5101, a CD19 CAR-T candidate manufactured at point-of-care

Galapagos and CellPoint presented encouraging initial data at ASH 2022 for GLPG5101, a CD19 CAR-T candidate manufactured at point-of-care

Galapagos NV (Euronext & NASDAQ: GLPG) and CellPoint (a Galapagos company) today presented encouraging initial data from the ongoing ATALANTA-1 Phase 1/2 study with GLPG5101 at the 64th Annual American Society of Hematology (ASH) Congress taking place in New Orleans, Louisiana, from 10-13 December. ATALANTA-1 is a Phase 1/2 study in heavily pre-treated rrNHL patients to evaluate the safety, ...

ByGalapagos NV


Context Therapeutics® Reports Encouraging Preliminary Phase 2 Data for ONA-XR in Metastatic Breast Cancer

Context Therapeutics® Reports Encouraging Preliminary Phase 2 Data for ONA-XR in Metastatic Breast Cancer

PHILADELPHIA, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, announced preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s novel, first-in-class, potent, ...

ByContext Therapeutics Inc.


Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant’s PFS Increases with Duration of Prior CDK4/6i in ER+, HER2- in Metastatic Setting

Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant’s PFS Increases with Duration of Prior CDK4/6i in ER+, HER2- in Metastatic Setting

Elacestrant demonstrated longer progression-free survival (PFS) vs SOC endocrine therapy with medians up to 8.6 months, positively associated with the duration of prior treatment with CDK4/6 inhibitors Elacestrant side effects were manageable and consistent with previously reported results Results demonstrate that elacestrant may have the potential to become a new standard of care as a ...

ByThe Menarini Group


XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina

XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina

Independent Data Monitoring Committee authorized proceeding to Phase 2 at highest dose level tested following review of clinical safety data from the Phase 1 dose escalation Phase 2 clinical data readouts on safety and efficacy of XC001 anticipated in 2022 Company plans to commence study startup of XC001 as an adjunct to CABG in 2H21, and clinical studies in additional cardiovascular ...

ByXyloCor Therapeutics


New and Encouraging Global Diabetes Market Research Shows People with Diabetes are More Motivated to Manage their Condition than Healthcare Providers May Realize

New and Encouraging Global Diabetes Market Research Shows People with Diabetes are More Motivated to Manage their Condition than Healthcare Providers May Realize

Key Research Survey Findings: 52 percent of healthcare providers agreed motivation is a major barrier to patients adhering to blood glucose monitoring compared to only 10 percent of people with diabetes who agreed motivation is a major barrier. Healthcare providers claimed they are recommending blood glucose management apps to only 25 percent of their patients, while 55% of patients who ...

ByLifeScan


Onconova Therapeutics Announces Plans For A Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer, Reports Third Quarter 2022 Financial Results, And Provides A Business Update

Onconova Therapeutics Announces Plans For A Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer, Reports Third Quarter 2022 Financial Results, And Provides A Business Update

Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced plans for a Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC). In addition, the Company reported its third ...

ByTraws Pharma


Galapagos to present encouraging initial data from FILOSOPHY real-world arthritis study at ACR Convergence 2022

Galapagos to present encouraging initial data from FILOSOPHY real-world arthritis study at ACR Convergence 2022

Galapagos NV (Euronext & NASDAQ: GLPG) will present new data on filgotinib at the American College of Rheumatology (ACR) Convergence 2022 meeting taking place in Philadelphia, Pennsylvania from 10-14 November 2022. Dr. Walid Abi-Saab, Chief Medical officer, at Galapagos said, “We are excited to present data at ACR which highlights our continued commitment to patients and the healthcare ...

ByGalapagos NV


Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023

Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023

Beyond Air, Inc. (NASDAQ: XAIR) a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced ...

ByBeyond Air Inc


Full-Scale PROTAC In Vivo Evaluation Services to Facilitate PROTAC Drug R&D

Full-Scale PROTAC In Vivo Evaluation Services to Facilitate PROTAC Drug R&D

In the process of drug development, the evaluation of drug effectiveness is one of the keys to determining whether prodrugs can sufficiently reach the market stage. BOC Sciences, as a professional contract research organization, can take care of the PROTAC in vivo evaluation workload for clients with a transparent project process and comprehensive evaluation reports to facilitate their PROTAC ...

ByBOC Sciences


Galapagos announces strategy to accelerate innovation and reports strong third quarter 2022 results

Galapagos announces strategy to accelerate innovation and reports strong third quarter 2022 results

Galapagos NV (Euronext & NASDAQ: GLPG) today announced its strategy for accelerated growth and value creation, its financial results for the first nine months of 2022, and the outlook for the remainder of 2022. The results are further detailed in the Q3 2022 financial report available on the financial reports section of the website. Forward, Faster strategy to accelerate innovation ...

ByGalapagos NV


GSK, MorphoSys’ Licensing Partner, Provides Update on ContRAst Phase III Program for Otilimab in Moderate to Severe Rheumatoid Arthritis

GSK, MorphoSys’ Licensing Partner, Provides Update on ContRAst Phase III Program for Otilimab in Moderate to Severe Rheumatoid Arthritis

MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner, GSK plc (LSE/NYSE: GSK), provided an update on the ContRAst phase III program for otilimab as a potential treatment of moderate to severe rheumatoid arthritis (RA). The ContRAst phase IIl program enrolled a broad range of difficult-to-treat patients who had an inadequate response to or could not tolerate available ...

ByMorphoSys AG


Intrommune Therapeutics Completes Enrollment in the Phase 1 OMEGA Study for Peanut Allergy

Intrommune Therapeutics Completes Enrollment in the Phase 1 OMEGA Study for Peanut Allergy

Observed only mild and transient adverse events, with no use of emergency epinephrine Observed 98.4% patient compliance to date with novel OMIT therapeutic modality Safely started patients on dose 4, potentially reducing the time to reach maintenance by several weeks NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage biotechnology ...

ByIntrommune Therapeutics


Beyond Air Announces Positive Data for Inhaled Nitric Oxide (NO) to Treat COVID-19 with LungFit® PRO in a Poster Presentation at IDWeek 2022

Beyond Air Announces Positive Data for Inhaled Nitric Oxide (NO) to Treat COVID-19 with LungFit® PRO in a Poster Presentation at IDWeek 2022

Beyond Air, Inc. (NASDAQ: XAIR), a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced ...

ByBeyond Air Inc

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