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
FDA Approves Roche's First Molecular Test for Malaria Screening in Blood Donors

The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria Malaria is a serious and potentially fatal paras...

March 27, 2024 | Wednesday | News

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