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381,351 Results for "monarch medical".
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Policy
MONARCH Platform for Bronchoscopy Receives Regulatory License for China
Johnson & Johnson MedTech* announced that the MONARCH Platform and MONARCH Bronchoscope have obtained regulatory approval in China.
November 13, 2023
·
5 min read
Biotech Beach
NeuroSigma Announces FDA 510(k) Submission for Second Generation Monarch eTNS System
NeuroSigma today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its second-generation Monarch eTNS System™ (Monarch 2.0).
November 7, 2023
·
1 min read
Biotech Beach
NeuroSigma Announces HSA Approval of the Monarch eTNS System in Singapore
NeuroSigma today announced approval of the Monarch eTNS System by Singapore’s Health Sciences Authority (HSA), the national body that regulates medical devices, therapeutics, and other healthcare products.
October 3, 2023
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2 min read
Policy
NeuroSigma Announces FDA Clearance of its Second-Generation Monarch eTNS System for Treating Pediatric ADHD
NeuroSigma announced that the U.S. Food and Drug Administration cleared use of NeuroSigma’s second-generation Monarch eTNS System for treating pediatric attention deficit hyperactivity disorder.
January 18, 2024
·
2 min read
Business
Semler Announces Investment in Monarch Medical Technologies
Semler Scientific, Inc. today announced an up to $5.0 million investment in privately-held Monarch Medical Technologies, LLC (Monarch) through the purchase of a senior secured convertible promissory note. Repayment of the note is secured by a first priority interest in all of Monarch’s assets.
December 12, 2022
·
5 min read
Drug Development
Corcept Initiates MONARCH – A Phase 2b Trial in Non-Alcoholic Steatohepatitis (NASH)
Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced it has initiated MONARCH, a Phase 2b trial of its proprietary selective cortisol modulator miricorilant in patients with non-alcoholic steatohepatitis (NASH).
October 26, 2023
·
3 min read
Press Releases
SPR® Therapeutics Unveils Long-term Data on SPRINT® PNS and Initial MONARCH™ Trial Update
July 16, 2024
·
5 min read
Job Trends
Lilly to Present Final Overall Survival Analysis from the MONARCH 3 Study of Verzenio® (abemaciclib) and Additional Results from Its Breast Cancer Portfolio at the 2023 San Antonio Breast Cancer Symposium
Eli Lilly and Company (NYSE: LLY) today announced results from the MONARCH 3 clinical trial, which will be presented in a late-breaking presentation during the 2023 San Antonio Breast Cancer Symposium (SABCS).
December 5, 2023
·
28 min read
Drug Development
Landmark 5-Year monarchE Outcome Data Demonstrate Verzenio® (abemaciclib)'s Long-Term Impact on Cancer Recurrence in High-Risk Early Breast Cancer
Eli Lilly and Company (NYSE: LLY) today announced five-year outcomes from a pre-planned analysis of the Phase 3 monarchE study evaluating two years of adjuvant Verzenio® (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer (EBC) at a high risk of recurrence.
October 20, 2023
·
25 min read
Deals
Alora Pharmaceuticals Celebrates Acquisition of Monarch Manufacturing Facility
Alora Pharmaceuticals, LLC, is pleased to announce that its wholly owned subsidiary, Sovereign Pharmaceuticals, LLC, has acquired, through bankruptcy proceedings, substantially all of Monarch PCM, LLC’s manufacturing capabilities located in Fort Worth, TX.
January 10, 2023
·
2 min read
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