regulatory
The Perfect Storm: Why 2025 Will Be the Year of GxP AI in Pharma
GxP AI, pharmaceutical manufacturing, regulatory compliance, data-driven innovation, quality management, drug development
EU PFAS Ban Threatens Pharmaceutical Packaging Industry: Challenges and Implications
PFAS ban, pharmaceutical packaging, EU regulations, supply chain disruption, chemical alternatives, environmental protection, drug safety
Stoke Therapeutics Announces Global Phase 3 EMPEROR Study Design for Zorevunersen in Dravet Syndrome
Dravet syndrome, zorevunersen, Phase 3 trial, EMPEROR study, seizure reduction, cognitive improvement, regulatory alignment
FDA Urges Enhanced Authority to Combat Pediatric and Neonatal Medical Device Shortages
FDA, Medical Device Shortages, Pediatric Patients, Neonatal Patients, Supply Chain Vulnerabilities, Regulatory Authority
DEA Unveils Special Registration Framework for Telehealth Prescribing of Controlled Substances
DEA Special Registration, Telehealth Prescribing, Controlled Substances, Telemedicine Flexibilities, Ryan Haight Act, Telemedicine Regulations
FDA Advisory Panels: Activity Levels Normalize After 2023 Surge
FDA advisory panels, adcomms, regulatory changes, advisory committee meetings
WuXi Biologics Divests Irish Vaccine Facility to Merck for $500 Million Amid Strategic Shift
WuXi Biologics, Merck, vaccine manufacturing facility, Dundalk, Ireland, asset sale, strategic shift, regulatory changes, Biosecure Act
2024 FDA Drug Approvals: Small Companies Make Significant Impact
FDA drug approvals 2024, small biotech companies, pharmaceutical industry, new drug approvals, regulatory updates.
Applied Therapeutics Undergoes Leadership Changes Amid FDA Rejection and Regulatory Challenges
Applied Therapeutics, leadership changes, FDA rejection, rare disease drug, govorestat, regulatory challenges
Novo Holdings to Finalize $16.5B Acquisition of Catalent Following Regulatory Clearance
Novo Holdings, Catalent, Acquisition, Regulatory Clearance, Life Sciences, Pharmaceutical Development