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
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
Rakuten Medical Initiates Global Phase 3 Trial of Alluminox™ Treatment for Head and Neck Cancer in India

The Company has been granted permission from the Indian Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical...

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
10x Genomics Wins Permanent Injunction Against NanoString's CosMx Products

10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, today announced that it has won an injunction in its patent litigation ...

May 18, 2023 | Thursday | News
FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

"Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," said Janet Maynard, M.D., M.H.S., direct...

May 15, 2023 | Monday | News
MediciNova granted new patent for MN-166 (ibudilast) in Europe for microorganism infection

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than February 2039. The allowed claims cover MN...

May 15, 2023 | Monday | News
China NMPA Approves TYVYT® Combo for EGFR-mutated NSCLC Patients Who Progressed After EGFR-TKI Therapy

This is the seventh NMPA-approved indication of TYVYT® (sintilimab injection). The first six indications of TYVYT® (sintilimab injection) are inclu...

May 10, 2023 | Wednesday | News

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