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Results For "European-Union"

229 News Found

ZIM Laboratories receives marketing authorization for Dimethyl Fumarate in Portugal
News | March 20, 2025

ZIM Laboratories receives marketing authorization for Dimethyl Fumarate in Portugal

Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis


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


Sun Pharma to acquire Nasdaq-listed Checkpoint Therapeutics
News | March 10, 2025

Sun Pharma to acquire Nasdaq-listed Checkpoint Therapeutics

Will add UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) to Sun Pharma's global onco-derm franchise


European Commission approves Biocon Biologics' Ustekinumab Biosimilar
News | February 21, 2025

European Commission approves Biocon Biologics' Ustekinumab Biosimilar

YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease


Merck’s Welireg receives European approval for two indications
News | February 19, 2025

Merck’s Welireg receives European approval for two indications

WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union


BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma
News | February 01, 2025

BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma

Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population


Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS
Drug Approval | January 23, 2025

Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS

The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS


European Commission expands Jemperli plus chemotherapy approval for endometrial cancer
Drug Approval | January 21, 2025

European Commission expands Jemperli plus chemotherapy approval for endometrial cancer

Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show statistically significant and clinically meaningful OS benefit in the overall population


Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas
Drug Approval | January 19, 2025

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas

This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo


Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy
Drug Approval | December 14, 2024

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months