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Results For "US-FDA"

374 News Found

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis
News | March 18, 2026

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025


GSK expands RSV vaccine to younger adults in US, targeting high-risk 18–49 age group
News | March 16, 2026

GSK expands RSV vaccine to younger adults in US, targeting high-risk 18–49 age group

Previously, Arexvy was authorized for adults 60 and older, and for those 50–59 with heightened risk


QIAGEN bags FDA nod for full GI testing on QIAstat-Dx Rise system
News | March 16, 2026

QIAGEN bags FDA nod for full GI testing on QIAstat-Dx Rise system

The approval means US laboratories can now run both respiratory and gastrointestinal panels on the high-throughput QIAstat-Dx Rise


FDA nod to LifeVac De Novo, paving for next-generation anti-choking device
Medical Device | March 12, 2026

FDA nod to LifeVac De Novo, paving for next-generation anti-choking device

The FDA classified LifeVac as a Class II medical device


Roche reports Phase III persevERA breast cancer trial results
Clinical Trials | March 11, 2026

Roche reports Phase III persevERA breast cancer trial results

Giredestrant shows promise despite missing primary goal


Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation
Medical Device | March 10, 2026

Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation

Cognita CXR leverages a proprietary vision-language model to analyze full chest X-ray studies and generate comprehensive preliminary findings


Neuland to launch commercial peptide facility in Hyderabad as global capacity tightens
News | March 10, 2026

Neuland to launch commercial peptide facility in Hyderabad as global capacity tightens

The first of four planned modules at the new plant is expected to come online by summer 2026


FDA nod to groundbreaking combo therapy for relapsed multiple myeloma
News | March 07, 2026

FDA nod to groundbreaking combo therapy for relapsed multiple myeloma

This new treatment option can redefine how we approach RRMM treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile


Teva and Blackstone Life Sciences strike $400m deal to advance promising IBD therapy
R&D | March 05, 2026

Teva and Blackstone Life Sciences strike $400m deal to advance promising IBD therapy

The funding will be spread over four years, with BXLS also eligible for regulatory and commercial milestones, plus royalties on worldwide sales