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Results For "US-FDA"

423 News Found

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


Granules clears US FDA audit
News | July 21, 2021

Granules clears US FDA audit

The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021


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