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8039 News Found

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market
News | September 05, 2025

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product


FDA completes inspection at Biocon Biologics' facility in Bengaluru
News | September 05, 2025

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations


CapVest to acquire majority stake in STADA
News | September 05, 2025

CapVest to acquire majority stake in STADA

Bain Capital and Cinven will each retain a minority stake, reflecting their ongoing confidence in STADA’s future growth


Resolution Therapeutics doses first patient in phase I/II Emerald study of RTX001 for end-stage liver disease
Clinical Trials | September 05, 2025

Resolution Therapeutics doses first patient in phase I/II Emerald study of RTX001 for end-stage liver disease

RTX001 represents a groundbreaking advance in the treatment of end-stage liver disease, offering new hope for patients with limited options


Merck’s oral PCSK9 inhibitor Enlicitide shows promising results in phase 3 CORALreef lipids study
Clinical Trials | September 04, 2025

Merck’s oral PCSK9 inhibitor Enlicitide shows promising results in phase 3 CORALreef lipids study

Enlicitide achieved all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol


Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
Drug Approval | September 04, 2025

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity


Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
Drug Approval | September 04, 2025

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure


Cupid’s B2B export order book stands at Rs. 100 Cr+
News | September 04, 2025

Cupid’s B2B export order book stands at Rs. 100 Cr+

These orders are from international government tenders in South Africa, Tanzania, and Kenya, as well as from international agencies WHO/UNFPA, NGOs like MSI and PSI


Syntegon reports H1 2025 EBITDA higher by 41% to €127 million
News | September 04, 2025

Syntegon reports H1 2025 EBITDA higher by 41% to €127 million

Free cash flow also reached €63 million, representing an 11 percent increase compared to the high benchmark set in 2024