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Results For "regulatory-approval"

316 News Found

Biocon receives Health Canada approval for Bosaya and Vevzuo biosimilars to Prolia and Xgeva
Biopharma | April 24, 2026

Biocon receives Health Canada approval for Bosaya and Vevzuo biosimilars to Prolia and Xgeva

Denosumab biosimilars approved in Canada to expand access for osteoporosis and cancer-related bone conditions


Gujarat Themis Biosyn to acquire anti-TB and anti-infective brands from Sanofi for EUR 158 Million
News | April 24, 2026

Gujarat Themis Biosyn to acquire anti-TB and anti-infective brands from Sanofi for EUR 158 Million

Deal includes 13 branded generic products across 55+ countries; acquisition expected to strengthen global anti-infective portfolio and expand regulated market presence


ECI taps industry veteran Khalid Raja to drive strategic growth
People | April 22, 2026

ECI taps industry veteran Khalid Raja to drive strategic growth

Move comes amid rising regulatory pressures


Strengthening India’s pharma brand through compliance-first manufacturing: Vijay Kumar Aggarwal, MD, Medicef Pharma
Opinion | April 21, 2026

Strengthening India’s pharma brand through compliance-first manufacturing: Vijay Kumar Aggarwal, MD, Medicef Pharma

By prioritising absolute compliance, leveraging the power of digital tools, and aligning with government policies, the sector is locking in its future leadership


CDSCO rolls out prior intimation system to fast-track drug testing and R&D
Drug Approval | April 21, 2026

CDSCO rolls out prior intimation system to fast-track drug testing and R&D

Shift from approvals to digital intimation via NSWS portal aims to cut timelines and boost innovation in early-stage drug development


Precision BioSciences expands Hepatitis B gene editing trial into France and Romania
Biotech | April 20, 2026

Precision BioSciences expands Hepatitis B gene editing trial into France and Romania

The Clinical Trial Application (CTA) approval clears the way for the company to launch trial locations in France and Romania


Clean Cells, Naobios step up Asia expansion at BIO KOREA 2026 in Seoul
Biotech | April 16, 2026

Clean Cells, Naobios step up Asia expansion at BIO KOREA 2026 in Seoul

The event marks a significant push into South Korea’s rapidly expanding bio-health ecosystem


Shalby Hospitals gets 5-year kidney transplant approval for Ahmedabad Krishna Unit
Hospitals | April 14, 2026

Shalby Hospitals gets 5-year kidney transplant approval for Ahmedabad Krishna Unit

The license is valid for five years, effective from April 9, 2026


Gilead to acquire Tubulis for up to $5 billion to strengthen its oncology portfolio
Biotech | April 09, 2026

Gilead to acquire Tubulis for up to $5 billion to strengthen its oncology portfolio

The acquisition complements Gilead’s existing oncology expertise and development infrastructure


Novartis strikes $3 billion deal to acquire next-gen breast cancer drug
News | March 25, 2026

Novartis strikes $3 billion deal to acquire next-gen breast cancer drug

SNV4818, the oral drug, is pan-mutant–selective PI3K? inhibitor aimed at treating HR+/HER2- breast cancer and potentially other solid tumors