News about "US Food and Drug Administration "

UPLIZNA Becomes First and Only FDA-Approved Therapy for IGG4-Related Disease

The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognising the high unmet medical need in this serious condition and the medicine's potential to benefit patients.

US Food And Drug Administration | 05/04/2025 | By Abha

Rznomics Liver Cancer Drug RZ-001 Secures Fast Track Designation from US FDA

Rznomics' anticancer drug RZ-001 has received Fast Track Designation from the US FDA for the treatment of liver cancer – Hepatocellular Carcinoma (HCC), marking its second designation after Glioblastoma (GBM), to accelerate its clinical development.

US Food And Drug Administration | 19/02/2025 | By Abha

Innate Pharma Secures FDA Granted BTD for Lacutamab

The BTD is granted based on Phase 1 study results as well as results from the Phase 2 TELLOMAK study, where lacutamab demonstrated encouraging efficacy and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sézary syndrome.

US Food And Drug Administration | 18/02/2025 | By Aishwarya

Shanghai MicuRx's MRX-5 Receives FDA Orphan Drug Designation for NTM Infections

MRX-5 is a novel benzoxazole antibiotic developed for treating mycobacteria infections, particularly infections caused by non-tuberculous mycobacteria (NTM).

US Food And Drug Administration | 03/01/2025 | By Abha

Ionis Receives FDA Approval of New Drug Application for Donidalorsen

Donidalorsen is designed to reduce the production of prekallikrein (PKK), interrupting the pathway that leads to HAE attacks.

US Food And Drug Administration | 06/11/2024 | By Aishwarya |  125

Verona Pharma Secures US FDA Approval of Ohtuvayre

Verona Pharma has announced that the US Food and Drug Administration (FDA) approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

US Food And Drug Administration | 27/06/2024 | By Aishwarya |  333

Novavax Submits Application to FDA for Updated JN.1 COVID-19 Vaccine

Novavax, Inc. has submitted an amendment to its Emergency Use Authorization to the US Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.

US Food And Drug Administration | 15/06/2024 | By Aishwarya |  135

FDA Grants IND Approval for Lomonitinib to Eilean Therapeutics

Eilean Therapeutics has announced that the US Food and Drug Administration (FDA) has cleared the IND for lomonitinib (ZE46-0134).

US Food And Drug Administration | 11/06/2024 | By Aishwarya |  308

US FDA Grants Priority Review to Sarclisa for Treatment of Transplant-Ineligible NDMM

Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab).

US Food And Drug Administration | 28/05/2024 | By Aishwarya |  278

Bristol Myers Squibb Gets US FDA Approval for Breyanzi

Bristol Myers Squibb has declared that US Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi.

US Food And Drug Administration | 17/05/2024 | By Aishwarya |  296