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Results For "regulatory-approval"

316 News Found

Apotex scores exclusive Canadian rights to testosterone therapy Nebido
News | February 07, 2026

Apotex scores exclusive Canadian rights to testosterone therapy Nebido

Under the agreement, Apotex’s branded division, Searchlight Pharma, will seek regulatory approval and handle marketing and distribution in Canada


Novo Nordisk threatens legal action over Hims & Hers ‘knockoff’ semaglutide pill
News | February 07, 2026

Novo Nordisk threatens legal action over Hims & Hers ‘knockoff’ semaglutide pill

The pharmaceutical giant said it would pursue legal and regulatory action following Hims & Hers


Budget 2026 -27: Pharma sector cheers Rs. 10,000 crore Biopharma plan
Policy | February 01, 2026

Budget 2026 -27: Pharma sector cheers Rs. 10,000 crore Biopharma plan

The Union Budget makes a clear and timely choice by placing biopharma at the centre of India’s next manufacturing wave


AstraZeneca expands obesity and diabetes pipeline with $1.2B CSPC deal
News | January 31, 2026

AstraZeneca expands obesity and diabetes pipeline with $1.2B CSPC deal

CSPC will receive an upfront $1.2 billion from AstraZeneca for access to eight programmes, AI molecular design capabilities, and the LiquidGel platform


Akums bags key EU GMP certifications for 2 Haridwar plants
News | January 24, 2026

Akums bags key EU GMP certifications for 2 Haridwar plants

Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms


Alteogen strikes $285M deal with GSK subsidiary for innovative cancer drug delivery
Biopharma | January 23, 2026

Alteogen strikes $285M deal with GSK subsidiary for innovative cancer drug delivery

This deal marks a major step for Alteogen as it pushes its Hybrozyme platform deeper into the oncology market


Dr Reddys Laboratories consolidated Q3 FY26 PAT drops to Rs. 1209.8 Cr, expands global pipeline
News | January 23, 2026

Dr Reddys Laboratories consolidated Q3 FY26 PAT drops to Rs. 1209.8 Cr, expands global pipeline

The company has posted net profit of Rs. 4,064.9 crore for the 9 months period ended December 31, 2025


Shionogi boosts stake in ViiV Healthcare in $2.125 billion deal, Pfizer exits
News | January 23, 2026

Shionogi boosts stake in ViiV Healthcare in $2.125 billion deal, Pfizer exits

Under the deal, ViiV Healthcare will issue new shares to Shionogi for $2.125 billion and cancel Pfizer’s holding


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