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
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
Singlera Genomics' PDACatch Gets FDA Breakthrough Designation for Pancreatic Cancer Liquid Biopsy

Pancreatic adenocarcinoma (PDAC) is one of the most deadly forms of cancer, in part due to the majority of diagnoses being late-stage; the five-year surviv...

May 09, 2023 | Tuesday | News
MIVI Q™ Revascularization System Clinical Trial for Stroke Treatment Completes Enrollment

The EVAQ Trial enrolled 121 patients at 17 centers globally. Data from the study will be used as part of an application to the U.S. Food and Drug Administr...

May 04, 2023 | Thursday | News
Nanox.ARC Imaging System Receives FDA Clearance, Pioneering a New Era in Medical Imaging

NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it has received a ...

May 02, 2023 | Tuesday | Regulatory
Aquavit Receives FDA Clearance for Two INDs to Initiate Clinical Trials With Its Botulinum Toxin

Aquavit will begin its Phase II/Phase III trials for DTX-023 (aqubotulinumtoxinA) and DTX-024 (aqubotulinumtoxinA with intradermal microinjector) under the...

May 01, 2023 | Monday | News
Roche's Columvi Gets CHMP Nod for Fixed-Duration Use in Diffuse Large B-cell Lymphoma

The recommendation is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete r...

April 27, 2023 | Thursday | Regulatory
VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA

The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features VySpine's NanoVy-HA technology in partnership with Promimic AB. NanoVy-HA is a process in which...

April 26, 2023 | Wednesday | Regulatory

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