BeiGene Secures Israeli Ministry of Health Approval for TEVIMBRA® in Treating Esophageal Squamous Cell Carcinoma

BeiGene, a global oncology company, announced that the Israeli Ministry of Health (IL MOH) has approved TEVIMBRA® (tislelizumab) as monotherapy for t...

September 18, 2024 | Wednesday | News
Nuance Pharma Expands Bentrio® Nasal Spray Reach Across East and South East Asia

Altamira Therapeutics announces the extension of its exclusive license with Nuance Pharma to cover Singapore, Malaysia, Thailand, Philippines, Indonesia,...

September 17, 2024 | Tuesday | News
T2 Biosystems Gains FDA Clearance for Pediatric Use of T2Candida® Panel

T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance gene...

September 17, 2024 | Tuesday | News
FDA Approves Roche’s OCREVUS ZUNOVO™ for Subcutaneous MS Treatment, Expanding Access for Patients

OCREVUS ZUNOVO™ has the potential to expand treatment options to centres without IV infrastructure or with IV constraints, like at a doctor's off...

September 16, 2024 | Monday | News
Japan Approves World's First Self-Amplifying mRNA COVID-19 Vaccine, KOSTAIVE®, Targeting Omicron JN.1 Subvariants

Approval underscores CSL and Arcturus Therapeutics' commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral disea...

September 13, 2024 | Friday | News
FDA Grants Seven Years of Market Exclusivity to YORVIPATH for Treating Hypoparathyroidism in Adults

U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in...

September 12, 2024 | Thursday | News
FDA Issues Warning Letters to Two Chinese Testing Labs Over Data Integrity and Animal Care Violations

Firms Provided Third-Party, Nonclinical Premarket Testing; Agency Review Ongoing U.S. Food and Drug Administration issued warni...

September 12, 2024 | Thursday | News
FDA Approves TREMFYA® as First Dual-Acting Interleukin-23 Inhibitor for Ulcerative Colitis Treatment

The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically signifi...

September 12, 2024 | Thursday | News
FDA Grants RMAT Designation to BridgeBio’s Investigational Gene Therapy BBP-812 for Canavan Disease

- Receipt of RMAT Designation is based on preliminary clinical evidence from the CANaspire Phase 1/2 clinical trial, which showed functional improvements...

September 11, 2024 | Wednesday | News
Sun Pharma and Moebius Medical Receive FDA Fast Track Designation for Osteoarthritis Treatment MM-II

Sun Pharma and Israel-based Moebius Medical Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) t...

September 09, 2024 | Monday | News
FDA Grants Full Approval for FILSPARI in Treating IgA Nephropathy, Marking Major Advancement in Kidney Disease Care

FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data sh...

September 06, 2024 | Friday | News
Moderna's Updated COVID-19 Vaccine Receives Positive Opinion from EMA, Targeting Omicron Variant JN.1

Moderna, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion r...

September 06, 2024 | Friday | News
European Medicines Agency Grants Orphan Drug Designation to SeaBeLife's SBL01 for Acute Liver Failure

Orphan designation shows recognition of therapeutic potential of drug candidate SBL01 targeting two regulated cell death pathways European Medicines A...

September 04, 2024 | Wednesday | News
U.S. FDA Grants Emergency Use Authorization for Updated Novavax COVID-19 Vaccine Targeting Current Variants

– The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for an updated version of the Novavax COVID-19 Vaccine,...

September 04, 2024 | Wednesday | News

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