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Results For "US-FDA"

451 News Found

FDA okays RIVANNA’s AI-powered Accuro XV ultrasound system
Medical Device | May 12, 2026

FDA okays RIVANNA’s AI-powered Accuro XV ultrasound system

The clearance marks a pivotal step forward for the company as it pushes deeper into AI-driven diagnostics and expands its clinical footprint in point-of-care imaging


Ajanta Pharma Q4 FY26 revenue surges 21% to Rs. 1,422 Crore; PAT climbs 18%
News | May 06, 2026

Ajanta Pharma Q4 FY26 revenue surges 21% to Rs. 1,422 Crore; PAT climbs 18%

FY26 revenue rises 17% to Rs. 5,453 crore as US generics business jumps 49% and adjusted EBITDA margin improves to 26% for the quarter


Cipla launches next-generation oscillometer 'Ciposcillo' for respiratory diagnostics
Medical Device | May 06, 2026

Cipla launches next-generation oscillometer 'Ciposcillo' for respiratory diagnostics

The device is designed for early and accurate diagnosis of obstructive airway diseases such as COPD, and Asthma


OneSource powers second generic semaglutide nod in Canada
Drug Approval | May 05, 2026

OneSource powers second generic semaglutide nod in Canada

Approval marks the second generic semaglutide clearance in Canada and strengthens OneSource’s position in complex injectable CDMO programs


OneSource Specialty Pharma's partners get Health Canada approval for generic Semaglutide injection
News | May 04, 2026

OneSource Specialty Pharma's partners get Health Canada approval for generic Semaglutide injection

Approval for generic Ozempic® in Canada strengthens OneSource’s global CDMO footprint in complex peptide injectable manufacturing


FDA advisory panel narrowly withholds support for AstraZeneca’s combo in breast cancer
News | May 04, 2026

FDA advisory panel narrowly withholds support for AstraZeneca’s combo in breast cancer

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor


FDA grants breakthrough status to Laguna's mRNA blood test for schizophrenia diagnosis
News | May 02, 2026

FDA grants breakthrough status to Laguna's mRNA blood test for schizophrenia diagnosis

The move puts a spotlight on one of psychiatry’s most persistent clinical challenges: misdiagnosis and delay


GSK wins regulatory boost for once-monthly liver drug efimosfermin in MASH push
News | April 30, 2026

GSK wins regulatory boost for once-monthly liver drug efimosfermin in MASH push

The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need


Sun Pharma Advanced Research Company to sell priority review voucher for $195 Million
R&D | April 30, 2026

Sun Pharma Advanced Research Company to sell priority review voucher for $195 Million

SPARC enters definitive agreement to monetise rare paediatric disease PRV, unlocking capital for R&D and strategic growth