news

Oct 28, 2021

Naviswiss secures FDA 510k clearance for Naviplan, an advanced planning solution for hip replacement surgery  On October 21, 2021, Naviswiss, a Swiss-based medical technology company, received approval from the FDA to commercialise Naviplan in the United States. Naviplan is a digital pre-operative planning ...

Oct 26, 2021

Ocular Therapeutix’s dry eye disease insert fails in phase 2 trial Ocular Therapeutix declared that its OTX-CSI (cyclosporine intracanalicular insert) for dry eye disease (DED) has flunked to reach the primary endpoint in the phase 2 clinical trial. The company has conducted the US-based, randomised, double-m...

Oct 21, 2021

Hologic to acquire Bolder Surgical for USD160 Million, expanding its Surgical Franchise  On October 14, 2021, Hologic, Inc., a global player in women's health, signed a definitive agreement to acquire Bolder Surgical. This US-based company offers advanced energy vessel sealing surgical devices for approxima...

Oct 19, 2021

Biogen’s tofersen fails to meet the primary goal in the Phase III ALS trial Biogen has announced that its investigational antisense drug, tofersen (BIIB067), flunked to meet the primary goal of Phase III VALOR clinical trial in superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) patients. Althou...

Oct 14, 2021

Syntellix obtains product approval for India On October 07, 2021, Syntellix obtained the license to bring five different product families of its revolutionary bioabsorbable magnesium-based implants to market from India's Central Drugs Standard Control Organisation (CDSCO) for the Indian market. With this approva...

Oct 12, 2021

Brickell Plans to Submit New Drug Application to FDA for gel Brickell Biotech will request the FDA in mid-2022 to approve its gel for excessive underarm sweating after decreasing sweat production and disease severity in two pivotal trials.  The gel achieved statistical significance in lessening the sever...

Oct 07, 2021

Amber Implants VCFix® spinal system obtains US FDA Breakthrough designation  On October 05, 2021, the US Food and Drug Administration (FDA) granted the Breakthrough Device Designation to VCFix® spinal system, a next-generation spinal implant for spinal injuries developed by Amber Implants, a Netherlands-bas...

Oct 05, 2021

Pfizer tightens DMD patient criteria after serious adverse events in phase 3 gene therapy trial Pfizer is tightening up the criteria for Duchenne muscular dystrophy patients to partake in phase 3 clinical trials of its experimental gene therapy after three severe events were cropping up in ongoing studies. Th...

Sep 30, 2021

RETINA-AI Health, Inc. declares positive pivotal study results for the RETINA-AI Galaxy™ autonomous Diabetic Retinopathy screening device On September 20, 2021, RETINA-AI Health, Inc. announced optimistic results from the pivotal study of the RETINA-AI Galaxy™, a multi-device compatible autonomous ...

Sep 28, 2021

Innovent, UNION Therapeutics Set to Advance Dermatology Market in China  Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast, a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China. Orismilast ...