Tag: Drug Approval

Pharmaceutical Regulatory Affairs Market Trends and Forecast 2025-2030

Biopharma

The pharmaceutical industry is undergoing rapid transformation, influenced by regulatory changes, technological advancements, and evolving market needs. Regulatory affairs play a critical role in ensuring...

AI in Pharma, biosimilars, digital health regulation, Drug Approval, global harmonization, market forecast 2025-2030, orphan drugs, personalized medicine, pharmaceutical regulatory affairs, regulatory outsourcing, regulatory trends

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Jan 2025

Biopharma

USA FDA Approves a New Non-Opioid Therapy for Acute Pain The U.S. Food and Drug Administration has officially approved for Journavx (suzetrigine) 50 mg oral tablets, marking the introduction...

BioPharma, BioTech, Clinical Trials, Drug Approval, EMA, FDA, Healthcare Pharma Regulations, Pharma News, Regulatory Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Oct 2024

Biopharma

USA FDA Authorizes Neoadjuvant and Adjuvant Nivolumab for Respectable NSCLC The FDA has approved Nivolumab (Opteva, Bristol Myers Squibb) in combination with platinum-based chemotherapy as a...

Biotech News, Cancer Treatment, Drug Approval, FDA Approval, Healthcare Updates, Medical Advancements, Medicines, Patient Care, Pharma News, Regulatory News

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – May 2024

Biopharma

USA EPA, FDA, and USDA Release Joint Biotechnology Regulatory Plan In alignment with President Biden’s Executive Order 14081, the EPA, FDA, and USDA have issued a coordinated plan to modernize...

Bio Pharma, Bio Tech, Biotech News, Biotechnology, Drug Approval, EMA, FDA, Global Health, Health News, Healthcare, Healthcare Innovation, Medical Updates, Pharma Industry, Pharma News, Pharma Regulations, Pharma Trends, Pharma2024, Pharmaceuticals, Regulatory Updates

The Role of Regulatory Tracking Software in Accelerating Drug Approval Processes

Digital Health

In order to distribute the products, pharmaceutical manufacturers must ensure compliancy with global and local regulations and provide the required testing and reporting to validate products, their...

Compliance Solutions, Drug Approval, Drug Registration, Regulatory Affairs, Regulatory Management, Regulatory Tracking Software