Roche and Amgen's New Lp(a) Test Receives FDA Breakthrough Device Designation

Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial inf...

May 22, 2024 | Wednesday | News
Roche’s Inavolisib Receives Breakthrough Designation for Advanced Breast Cancer Treatment

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with pa...

May 21, 2024 | Tuesday | News
Atraverse Medical's HOTWIRE™ RF Guidewire Receives FDA Clearance, Revolutionizing Left-Heart Access

Atraverse Medical, a San Diego-based medical device company, announces the FDA clearance of its HOTWIRE™ radiofrequency (RF) guidewire, a novel devic...

May 15, 2024 | Wednesday | News
Baxter’s Clinolipid Receives U.S. FDA Approval for Pediatric Use, Expanding Access to Vital Nutrition Therapy

Baxter International Inc. (NYSE: BAX), a pioneer in nutrition therapy, proudly announces the United States Food and Drug Administration (FDA) approval of a...

May 14, 2024 | Tuesday | News
Moderna's Investigational RSV Vaccine Review Delayed by FDA

Moderna, Inc. received notification from the U.S. Food and Drug Administration (FDA) regarding a delay in the review process for its investigational respir...

May 13, 2024 | Monday | News
BrioHealth Solutions Granted FDA Approval to Commence Landmark Trial for Novel Heart Failure Treatment

BrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, announced it has received FDA I...

May 02, 2024 | Thursday | News
Beacon Biosignals & Takeda Forge Partnership to Elevate Sleep Disorder Biomarkers

Beacon Biosignals, the leader in at-home EEG and computational neurodiagnostics, announced a collaboration with Takeda to conduct at-home sleep monitoring ...

May 01, 2024 | Wednesday | News
NKGen Biotech's SNK01 NK Cell Therapy Clears FDA IND Hurdle for Parkinson’s

The Company expects to initiate a Phase 1 clinical trial in PD in 2H 2024. NKGen Biotech, Inc. , a clinical-stage biotechnology company focused on the dev...

April 30, 2024 | Tuesday | News
Zydus Launches Generic Mirabegron Extended-Release Tablets, Enhancing Access to Overactive Bladder Treatment in the US

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extende...

April 23, 2024 | Tuesday | News
Sanofi's Breakthrough BTK Inhibitor Shows Promise for Patients with Persistent and Chronic ITP, Regulatory Submissions Expected Soon

Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia Pivotal data from the first phase 3 study of a BTKi in immune thrombo...

April 23, 2024 | Tuesday | News
Lumicell Receives FDA Approval for LUMISIGHT™ and Lumicell™ Direct Visualization System, Revolutionizing Breast Cancer Surgery

LUMISIGHT™ and Lumicell™ Direct Visualization System (DVS) offer 84% diagnostic accuracy in detecting residual cancer, in real-time, that may h...

April 18, 2024 | Thursday | News
Shorla Oncology's Palatable Oral Liquid for Leukemia Enters FDA Review Process

Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced  that the U.S. Food and Drug Administration (FDA) h...

April 08, 2024 | Monday | News
Key Proteo Advances Early Detection of Rare Genetic Disorders with FDA Submission of Newborn Screening Kit

Key Proteo, a pioneering proteomics diagnostics company specializing in the enhanced early detection of rare but treatable genetic disorders, today announc...

April 01, 2024 | Monday | News
LISCure Biosciences' LB-P8 Granted Fast Track Designation by FDA for Primary Sclerosing Cholangitis Treatment

LISCure Biosciences, a leading clinical-stage biopharmaceutical company focused on discovering and developing innovative microbiome-based therapies, a...

April 01, 2024 | Monday | News

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