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Results For "approval"

2479 News Found

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


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


Syngene acquires first US biologics facility for $36.5 million
News | March 11, 2025

Syngene acquires first US biologics facility for $36.5 million

Overall investment in the US facility is estimated around US$50 million


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


Astellas and YASKAWA to establish JV focused on cell therapy manufacturing
News | March 10, 2025

Astellas and YASKAWA to establish JV focused on cell therapy manufacturing

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


Medicamen Biotech partners with South African business conglomerate
News | March 07, 2025

Medicamen Biotech partners with South African business conglomerate

The recent EU approval of MBL's plant has opened new avenues to explore such opportunities


Lupin Launches Rivaroxaban Tablets USP, 2.5mg in US
Drug Approval | March 07, 2025

Lupin Launches Rivaroxaban Tablets USP, 2.5mg in US

Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals