FDA Approval

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma

PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large […]

GE Healthcare Announces U.S. FDA Approval of Macrocyclic MRI Contrast Agent Clariscan™ (Gadoterate Meglumine) in Pre-Filled Syringes

U.S. FDA approves pre-filled syringe packaging for the macrocyclic gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine). Clariscan has been approved in more than 70 countries globally, with more than seven million patient doses shipped, and now offers a wider range of packaging solutions. Clariscan in pre-filled syringes offers potential advantages for workflow safety and efficiency. GE […]

FDA: Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

U.S. Food and Drug Administration issued the following announcement on Nov. 6. The U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The […]

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain

• U.S. commercialization expected to begin in the first half of 2021  • Continues positive momentum for Mainstay, with increasing commercial footprint in Europe and expected launch in Australia in early 2021  Dublin – Ireland, 22 June 2020 – Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) […]

Rebiotix and Ferring announce world’s first with positive preliminary pivotal Phase 3 data for investigational microbiome-based therapy RBX2660

Rebiotix and Ferring are the first to announce positive preliminary results on primary efficacy endpoint from ongoing pivotal Phase 3 clinical trial for RBX2660 RBX2660 is an investigational, non-antibiotic, microbiome-based therapy, developed to reduce Clostridiodes difficile (C. diff) infection recurrences CDC defines C. diff as a major burden to patients and doctors and an urgent […]

PhysIQ’s Proprietary Personalized Analytics to be Used for COVID-19 Care with Newly Broadened FDA Labeling

PhysIQ announces FDA-sanctioned labeling to address the COVID-19 public health emergency with its proprietary Multivariate Change Index (MCI) Deployed within the pinpointIQ® continuous remote monitoring solution, physIQ’s MCI will be used to proactively monitor homebound patients with or vulnerable to COVID-19 The sophisticated, machine learning-based algorithm uses multiple continuous vital signs from wearable sensors to detect […]

FDA Grants Breakthrough Device Designation to Bio-Techne ExoDx™ Prostate Intelliscore™ (EPI) Test

MINNEAPOLIS, June 17, 2019 /PRNewswire/ — Bio-Techne today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation. This designation not only validates the clinical importance of Bio-Techne’s EPI test, […]

FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

One in Two Women in the United States Will Suffer a Fracture in Her Lifetime Due to Osteoporosis(1) EVENITY is the First and Only Bone Builder With a Dual Effect That Both Increases Bone Formation and Decreases Bone Loss(2) EVENITY Rapidly Reduces Fracture Risk and Builds New Bone With 12 Months of Therapy(2) THOUSAND OAKS, […]

2019 Q1 Investment Report

Healthcare’s Move from Volume to Value Fuels Startup Investment As industry leaders work to redefine value in healthcare, payers and providers are offering access to the once-impenetrable healthcare marketplace for new technologies. As large healthcare systems and payers expand their own investment portfolios, they are becoming familiar with the value that startups can drive and […]

Medical Alley Companies Raise The Bar Again

Records Fall in Q1 As Money Flows Into Medical Alley’s Startup and Growth-Stage Companies After setting a record with their best-ever Q1 in 2018, Medical Alley startup companies didn’t just set the record again, they shattered it! For the third consecutive year, Medical Alley startup and growth-stage companies broke the previous record for money raised […]