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Results For "FDA"

2194 News Found

Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma
News | January 07, 2026

Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma

Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide


MetaVia’s DA-1726 shows breakthrough weight loss in Phase 1 trial
Biotech | January 07, 2026

MetaVia’s DA-1726 shows breakthrough weight loss in Phase 1 trial

Fasting glucose improved by 12.3 mg/dL, while liver stiffness dropped 23.7%, signaling a direct hepatic benefit


Medera doses final patient in high-dose HFpEF gene therapy trial
Biopharma | January 07, 2026

Medera doses final patient in high-dose HFpEF gene therapy trial

Heart failure affects an estimated 64.3 million people worldwide


Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China
Biopharma | January 07, 2026

Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China

Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001


Reimagining India’s Pharmaceutical Sector: From Global Supplier to Innovation Leader
Opinion | January 07, 2026

Reimagining India’s Pharmaceutical Sector: From Global Supplier to Innovation Leader

India should explore Sustainability-Linked Incentives (SLI) targeting innovations in the 12 principles of green chemistry


RedHill Biopharma advances RHB-102 as once-daily oral therapy to combat GLP-1 side effects
Clinical Trials | January 06, 2026

RedHill Biopharma advances RHB-102 as once-daily oral therapy to combat GLP-1 side effects

The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation


Nia Therapeutics unveils first implantable brain interface for memory disorders
News | January 06, 2026

Nia Therapeutics unveils first implantable brain interface for memory disorders

The SNS records neural activity from 60 channels across four brain regions—far exceeding current commercial devices


Elanco scores USDA nod for new canine allergy drug Befrena
News | January 04, 2026

Elanco scores USDA nod for new canine allergy drug Befrena

Elanco expects Befrena to launch in the US in the first half of 2026


Kokilaben Dhirubhai Ambani Hospital makes history with India’s first intercontinental remote robotic surgeries
Hospitals | December 31, 2025

Kokilaben Dhirubhai Ambani Hospital makes history with India’s first intercontinental remote robotic surgeries

The Toumai platform, currently the only robotic system with US FDA Study Approval for telesurgery, enabled real-time surgical control with no compromise to patient safety


Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial
Clinical Trials | December 29, 2025

Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial

Lucid-MS represents a potential breakthrough in the treatment of multiple sclerosis