Moderna Secures European Commission Approval for First mRNA RSV Vaccine, mRESVIA®

Moderna, Inc. announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial...

August 26, 2024 | Monday | News
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
Brains Bioceutical on Track to Achieve One of the World’s First CEP Certifications for Cannabidiol with EDQM Approval

Brains Bioceutical Set to Achieve One of the World’s First CEP for Cannabidiol Certification with the European Directorate for the Quality of Medic...

August 22, 2024 | Thursday | 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
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
Alcura Receives MIA License for Cell and Gene Therapies, Expanding CGT Support Across Europe

Alcura, a provider of specialized clinical trial services and a part of Cencora, has been granted a Manufacturing and Importation Authorization (MIA) lic...

August 15, 2024 | Thursday | News
Eisai and Biogen Announce Middle East Approval of Alzheimer’s Drug LEQEMBI® (lecanemab) in the UAE

Eisai Co., Ltd. and Biogen Inc. are pleased to announce that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved the hum...

August 15, 2024 | Thursday | News
BioSenic Secures Key Japanese Patent for Enhanced Arsenic-Based Therapeutics in Autoimmune and Cancer Treatments

Composition-of-matter patent covers the therapeutic use of arsenic salts and metal ions through various routes of administration. Enriched IP portfoli...

August 14, 2024 | Wednesday | News
Mangoceuticals Secures 20-Year Patent in India for Innovative Preventive Health Technology

Mangoceuticals, Inc. \ a company focused on developing, marketing, and selling a variety of men’s health and wellness products in the area of ...

August 14, 2024 | Wednesday | News
Shanghai Junshi Biosciences’ Toripalimab sNDA Accepted by NMPA for First-Line Treatment of Advanced Melanoma

Shanghai Junshi Biosciences Co., a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of ...

August 13, 2024 | Tuesday | 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
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

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