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Results For "BLA"

416 News Found

Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy
Drug Approval | February 24, 2026

Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy

If approved, DTX401 would be the first treatment to address the disease at its root cause


Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar
Clinical Trials | February 23, 2026

Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar

BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data


CARE Hospitals positions workforce health as a strategic business imperative at HR Conclave 2026
News | February 23, 2026

CARE Hospitals positions workforce health as a strategic business imperative at HR Conclave 2026

200+ HR leaders and CXOs convened to discuss workforce health, preventive care, and organisational wellbeing as strategic business priorities


AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
News | February 05, 2026

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)


FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus
Drug Approval | February 05, 2026

FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available


Fides launches imaging CRO focused on early-phase clinical decision-making
News | January 30, 2026

Fides launches imaging CRO focused on early-phase clinical decision-making

Fid?s brings core strengths across imaging applications and human biology, supporting work in digestive disease, GI oncology, and select solid tumors


Pangea Laboratory teams with Gene Solutions to bring AI-driven cancer tests to US patients
Biotech | January 28, 2026

Pangea Laboratory teams with Gene Solutions to bring AI-driven cancer tests to US patients

Pangea will use its integrated validation platform and regulatory expertise to oversee analytical and clinical validation of Gene Solutions’ multi-omics technologies.


Dr Reddys Laboratories consolidated Q3 FY26 PAT drops to Rs. 1209.8 Cr, expands global pipeline
News | January 23, 2026

Dr Reddys Laboratories consolidated Q3 FY26 PAT drops to Rs. 1209.8 Cr, expands global pipeline

The company has posted net profit of Rs. 4,064.9 crore for the 9 months period ended December 31, 2025