Sibel Health Expands Capabilities with New FDA Clearances for ANNE® Wearable Sensors

Sibel Health announces two additional FDA-clearances enabling its advanced wearable sensors to operate with compatible third party software applications. I...

August 23, 2024 | Friday | News
FDA Accepts Application for Opdivo Plus Yervoy as First-Line Treatment for Unresectable Hepatocellular Carcinoma

Acceptance based on Phase 3 CheckMate -9DW trial results demonstrating improved survival with Opdivo (nivolumab) plus Yervoy(ipilimumab) compared to in...

August 22, 2024 | Thursday | News
Phanes Therapeutics Secures FDA Orphan Drug Designation for PT217 in Treating Neuroendocrine Carcinoma

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today th...

August 19, 2024 | Monday | News
Lykos Therapeutics Restructures to Focus on Resubmission of NDA for PTSD Treatment Midomafetamine

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, today announced a reorganization to best support the company as...

August 16, 2024 | Friday | News
Gilead Sciences Announces FDA Accelerated Approval for Livdelzi® in Treating Primary Biliary Cholangitis

Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) fo...

August 15, 2024 | Thursday | News
Stereotaxis Announces CE Mark Approval and FDA Submission for Revolutionary GenesisX Robotic System

Stereotaxis, a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE mark in Eu...

August 13, 2024 | Tuesday | News
Ascendis Pharma’s YORVIPATH® Offers Continuous PTH Therapy, Meeting Critical Needs of Over 70,000 U.S. Hypoparathyroidism Patients

Hypoparathyroidism is a rare endocrine disease with multi-organ impacts affecting an estimated 70,000 to 90,000 people in the United States Ascendi...

August 12, 2024 | Monday | News
FDA Approves First Non-Injection Epinephrine Nasal Spray, Neffy, for Life-Threatening Allergic Reactions

U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those th...

August 12, 2024 | Monday | News
Novartis' Fabhalta® Receives FDA Accelerated Approval for IgA Nephropathy Treatment

Novartis is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta® (iptacopan), a ground...

August 08, 2024 | Thursday | News
Thermo Fisher Scientific's SeCore™ CDx HLA A Sequencing System Receives FDA Clearance as Companion Diagnostic for Adaptimmune’s TECELRA® TCR Therapy

Thermo Fisher Scientific Inc., the world leader in serving science,  announced that its SeCore™ CDx HLA A Sequencing System has been granted 5...

August 07, 2024 | Wednesday | News
Agilent Receives FDA Approval for MAGE-A4 IHC 1F9 pharmDx as a Diagnostic Tool for Use with Newly Approved TCR T-Cell Therapy

Agilent that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovia...

August 05, 2024 | Monday | News
FDA Grants Accelerated Approval for TECELRA in Advanced Synovial Sarcoma Treatment

Approved for advanced MAGE-A4+synovial sarcoma in adults with certain HLA types who have received prior chemotherapy TECELRA is the first new treatment ...

August 02, 2024 | Friday | News
FDA Grants Priority Review to Vertex's Suzetrigine, Targeting January 2025 for Action Date

FDA grants priority review and assigns a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025 – – Suzetrigine...

July 30, 2024 | Tuesday | News
Varian Receives FDA Clearance for Enhanced Ethos 2.0 Therapy System, Streamlining Adaptive Radiotherapy

Varian, a Siemens Healthineers company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new functionality to its ...

July 23, 2024 | Tuesday | News

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