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
Croma-Pharma announces enrollment of first patient in hyaluronic acid dermal filler clinical trial in China

The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial1 is being led by Lanhzou Biotechnique Development  wi...

June 13, 2023 | Tuesday | 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
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
Agilent Announces Full Workflow for US EPA Method 1633 for Targeted PFAS Analysis

Agilent Technologies Inc. (NYSE: A) announced today a highly-anticipated, complete workflow solution for targeted per- and polyfluoroalkyl substances (PFAS...

June 07, 2023 | Wednesday | 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
Ascentage Pharma's Olverembatinib Recommended for Second Breakthrough Therapy Designation in China for SDH-Deficient GIST

This marks the second BTD granted to olverembatinib by the CDE, with the first one granted in March 2021 for the treatment of patients with chronic-phase c...

May 31, 2023 | Wednesday | 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
New CapnoPen® CP-001k receives CE certification (MDR)

Stéphane Rohan Laurent, Capnopharm’s VP Sales & Business Development, comments: “Receiving CE certification constitutes a landm...

May 31, 2023 | Wednesday | News
SK bioscience Receives Marketing Authorization for its COVID-19 Vaccine from UK MHRA

 SKYCovion is the world’s first-ever vaccine developed using the RoseTTAFold, a software tool that uses deep learning. SK bioscience has appl...

May 30, 2023 | Tuesday | 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
Catalent Strengthens Cryogenic Capabilities in Shiga, Japan, Facility for Cell and Gene Therapy

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational ...

May 25, 2023 | Thursday | News

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