FDA Approves Bylvay® for Alagille Syndrome's Cholestatic Pruritus

Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related ...

June 14, 2023 | Wednesday | News
Neuronetics Receives 510(k) Clearance for OCD MT Cap for NeuroStar Advanced Therapy

Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life fo...

June 13, 2023 | Tuesday | News
Stay Informed: FDA Roundup for June 9, 2023

FDA provided information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. The FDA issued this letter to ...

June 12, 2023 | Monday | News
Bristol Myers Squibb Receives U.S. FDA Approval of New State-of-the-Art Cell Therapy Manufacturing Facility

Bristol Myers Squibb (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) has approved commercial production at the company’s...

June 12, 2023 | Monday | News
FDA Committee Unanimously Recommends Nirsevimab as First RSV Immunization for Infants

Nirsevimab would be the first immunization specifically designed to protect all infants through their first RSV season, if approved Across all clinical ...

June 09, 2023 | Friday | News
Janssen Seeks FDA Approval for CARVYKTI® in Early Treatment of Multiple Myeloma

Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progre...

June 07, 2023 | Wednesday | News
OnQuality's OQL051 Granted FDA Clearance for Chemotherapy-Induced Diarrhea Prophylaxis

CID is a common and often debilitating toxicity affecting up to 90% of patients receiving chemotherapy. CID can cause dehydration, electrolyte imbalance, m...

June 07, 2023 | Wednesday | News
GE Healthcare Introduces Sonic DL: FDA-Cleared AI for Faster MRI.

Sonic DLi is a deep learning (DL) technology that acquires high-quality magnetic resonance (MR) images up to 12 timesii faster than conventional methods,...

June 06, 2023 | Tuesday | News
GE HealthCare's New Deep Learning Solution Cleared by FDA for Enhanced PET/CT Image Quality, Reinforcing AI Leadership

A type of artificial intelligence (AI), Deep Learning (DL) technology can advance medical imaging capabilities by providing more robust, accurate, and da...

May 31, 2023 | Wednesday | News
Lexicon's INPEFA™ (sotagliflozin) FDA Approved for Heart Failure Treatment

INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to ...

May 29, 2023 | Monday | News
Iovance Biotherapeutics' Lifileucel for Advanced Melanoma Receives FDA Acceptance

First Potential Approval of an Individualized, One-Time Cell Therapy  for Patients with Advanced Melanoma Iovance Biotherapeutics, Inc. (NASDAQ: IOVA...

May 29, 2023 | Monday | Regulatory
FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human ...

May 24, 2023 | Wednesday | News
Indivior Receives FDA Approval for OPVEE® Nasal Spray, Opioid Overdose Rescue Medicine

In the 12-month period ending in December 2022, over 79,000 people in the U.S. were reported to have died of an opioid overdose, of whi...

May 23, 2023 | Tuesday | News
Thermo Fisher Scientific's Immunoassays Receive FDA Clearance for Preeclampsia Risk Assessment

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleare...

May 20, 2023 | Saturday | News

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