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Results For "U.S.-Food-and-Drug-Administration"

609 News Found

Roche breaks lab barriers as FDA clears mass spec tests for wider use
News | March 20, 2026

Roche breaks lab barriers as FDA clears mass spec tests for wider use

The newly classified assays join Roche’s Ionify 25-Hydroxy Vitamin D total assay in a growing U.S. portfolio


Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Drug Approval | March 13, 2026

Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA

Marks significant milestone for breakthrough biologic to treat rare blood cancers


FDA nod to first treatment for rare genetic brain disorder
Drug Approval | March 12, 2026

FDA nod to first treatment for rare genetic brain disorder

The approval comes after a systematic review of published literature


SEQSTER launches 1-Click DataLake, unlocking real-world health data from 150M+ patients
Digitisation | March 09, 2026

SEQSTER launches 1-Click DataLake, unlocking real-world health data from 150M+ patients

The company says those insights can power advanced analytics and real-world evidence (RWE), helping researchers improve trial design, study feasibility, and recruitment strategies


Merck delivers resilient 2025 performance despite global headwinds
News | March 06, 2026

Merck delivers resilient 2025 performance despite global headwinds

Strong performances in its Life Science, Healthcare and Electronics divisions — particularly Process Solutions, Cardiovascular treatments and Semiconductor Materials — powered the company’s results


Bayer expands MRXperion power injector capabilities with FDA nod
News | March 06, 2026

Bayer expands MRXperion power injector capabilities with FDA nod

The system also introduces Imaging Scanner Interface 2 (ISI2) capability, enabling direct communication between injector and scanner to improve exam coordination and operational efficiency


Iza-bren delivers dual survival win in phase III trial for hard-to-treat breast cancer
Clinical Trials | March 02, 2026

Iza-bren delivers dual survival win in phase III trial for hard-to-treat breast cancer

Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival


Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe
News | February 28, 2026

Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe

AA, a chronic immune disease, can cause extensive and unpredictable hair loss


Gilead to acquire Arcellx in $7.8 billion bet on next-generation CAR T therapy
Biotech | February 26, 2026

Gilead to acquire Arcellx in $7.8 billion bet on next-generation CAR T therapy

Arcellx develops innovative immunotherapies for cancer and other incurable diseases


iRegene doses first US Parkinson’s patient, launches landmark MSA trial in China
Clinical Trials | February 24, 2026

iRegene doses first US Parkinson’s patient, launches landmark MSA trial in China

The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration