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Results For "approval"

2615 News Found

Akums launches Ripasudil + Timolol combination for glaucoma treatment
News | April 01, 2025

Akums launches Ripasudil + Timolol combination for glaucoma treatment

The new combination therapy offers a dual mechanism of action for superior intraocular pressure control


Curium completes acquisition of Monrol
News | March 29, 2025

Curium completes acquisition of Monrol

Positions Curium as leading manufacturer of Lu-177 isotope


European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease
Drug Approval | March 27, 2025

European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease

EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults


Bio-Thera & Dr Reddy’s execute commercialization pact for biosimilars Stelara & Simponi for SE Asia
News | March 27, 2025

Bio-Thera & Dr Reddy’s execute commercialization pact for biosimilars Stelara & Simponi for SE Asia

Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506


Merck inks $200 million deal for Hengrui's midstage heart disease drug
News | March 26, 2025

Merck inks $200 million deal for Hengrui's midstage heart disease drug

Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region


SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
Drug Approval | March 22, 2025

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483


USFDA grants Priority Review for new indication of finerenone for patients with common heart failure
Drug Approval | March 20, 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


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


RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes


Anupriya Patel inaugurates India Innovation Summit – Pioneering Solutions to End TB
Policy | March 19, 2025

Anupriya Patel inaugurates India Innovation Summit – Pioneering Solutions to End TB

TB treatment coverage in India increased by 32% in the last eight years from 53% in 2015 to 85% in 2023