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

642 News Found

Glenmark Pharmaceuticals accelerates U.S. strategy with direct RYALTRIS distribution
News | April 02, 2026

Glenmark Pharmaceuticals accelerates U.S. strategy with direct RYALTRIS distribution

This marks a meaningful step in the company's continued expansion in the region


AbbVie stakes claim to redefine skin disease treatment at Global Dermatology Summit
R&D | March 28, 2026

AbbVie stakes claim to redefine skin disease treatment at Global Dermatology Summit

Beyond clinical trials, real-world evidence is adding weight to AbbVie’s claims


Merck strikes $6.7 billion deal to acquire terns, bolstering cancer pipeline
News | March 26, 2026

Merck strikes $6.7 billion deal to acquire terns, bolstering cancer pipeline

TERN-701, a next-generation therapy targeting chronic myeloid leukemia (CML), a form of blood cancer that still presents treatment challenges despite decades of advances


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