Singapore Launches Subsidy Program for Pioneering Cell, Tissue, and Gene Therapies

Singaporean government has introduced a subsidy program to make cell, tissue, and gene therapy products (CTGTP) more accessible to patients. Begi...

September 04, 2024 | Wednesday | News
Guardant Health Japan Receives MHLW Approval for First Blood-Based Diagnostic Test for EGFR Exon 20 Insertion Mutations in NSCLC

Guardant Health Japan Corp. (HQ: Minato-ku, Tokyo/ Representative Director: Mika Takaki), a leading precision oncology company, announced that the M...

September 03, 2024 | Tuesday | News
GSK's Nucala Becomes First and Only Biologic Approved in Japan for CRSwNP with Four-Weekly Dosing Schedule

Nucala is the first and only biologic in Japan with a four-weekly dosing schedule for this condition Chronic rhinosinusitis with nasal polyps (CRSwNP)...

August 29, 2024 | Thursday | News
Novartis’ Leqvio® (inclisiran) Outperforms Placebo and Ezetimibe in Phase III V-MONO Study for LDL-C Reduction

Phase III V-MONO study met its primary endpoints, demonstrating superiority of Leqvio (inclisiran) monotherapy vs both placebo and ezetimibe in LDL-C r...

August 29, 2024 | Thursday | News
Eli Lilly Launches Affordable Zepbound® Single-Dose Vials for Self-Pay Patients, Offering Over 50% Savings on Obesity Treatment

Distributed through LillyDirect®'s self-pay channel, Zepbound single-dose vials are at least 50% less than the list price of all other incr...

August 28, 2024 | Wednesday | News
BeiGene's Investigational BTK Degrader BGB-16673 Receives FDA Fast Track Designation for Relapsed CLL/SLL

BeiGene, a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an ...

August 27, 2024 | Tuesday | News
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

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