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Results For "medical-devices"

247 News Found

Poly Medicure receives MDR certification for 54 products
News | March 12, 2025

Poly Medicure receives MDR certification for 54 products

The MDR certification reafirms that these products meet the highest safety, quality, and regulatory standards


Nectar Lifesciences receives 7 observations from EDQM for API facility
News | March 12, 2025

Nectar Lifesciences receives 7 observations from EDQM for API facility

The European regulator will conduct a re-inspection of the facility to verify the compliance


Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer
Drug Approval | February 20, 2025

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved


Budget 2025: Industry expects tax incentives and thrust on affordable healthcare
Policy | January 23, 2025

Budget 2025: Industry expects tax incentives and thrust on affordable healthcare

Expand the scope of the Production-Linked Incentive (PLI) scheme and increase its allocation to cover more pharmaceutical products and raw materials


Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby
News | January 16, 2025

Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby

Morepen Laboratories approves hiving off of medical devices business


USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs
Policy | January 16, 2025

USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs

The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats


Aragen secures $100 million investment from Quadria Capital
News | January 13, 2025

Aragen secures $100 million investment from Quadria Capital

Investment will fund expansion to meet rising demand for CRDMO services


GEON Performance Solutions acquires Foster Corporation
News | January 09, 2025

GEON Performance Solutions acquires Foster Corporation

Acquisition expands high-value medical platform


Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara
News | January 07, 2025

Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara

The biosimilar Ustekinumab has been developed and manufactured by the company