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Results For "regulatory-approval"

338 News Found

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator
News | January 23, 2026

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator

This marks the second indication for which gumokimab has gained NDA review acceptance


Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera
News | January 11, 2026

Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera

Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories


Shilpa Medicare aims for US approval of chemo nausea drug
News | January 09, 2026

Shilpa Medicare aims for US approval of chemo nausea drug

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections


Lilly to buy Ventyx Biosciences for $1.2 billion
News | January 08, 2026

Lilly to buy Ventyx Biosciences for $1.2 billion

Ventyx's clinical pipeline includes multiple small molecules with potential for oral therapies addressing chronic inflammation


Cupid reports record Q3, eyes GCC expansion with Saudi FMCG facility
News | January 03, 2026

Cupid reports record Q3, eyes GCC expansion with Saudi FMCG facility

Cupid is strengthening its footprint in the GCC region, focusing on supply responsiveness and market proximity


Sanofi to acquire Dynavax in $2.2 billion deal, bolstering adult vaccine portfolio
News | December 26, 2025

Sanofi to acquire Dynavax in $2.2 billion deal, bolstering adult vaccine portfolio

The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities


Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613
Biopharma | December 24, 2025

Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613

The therapy targets the LRRC15 protein and is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.


Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar
News | December 23, 2025

Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar

Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized