regulatory
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
Navigating JPM Week 2024: Insights and Opportunities in Biopharma
JPM Week 2024, Biopharma, Industry Insights, Networking, Deal-making, Investment, M&A, IPOs, Regulatory Trends
GSK Advances Regulatory Filings for Linerixibat Following Successful Phase 3 Trial in PBC Itch Treatment
GSK, Linerixibat, PBC Itch, Phase 3 Trial, Regulatory Filings, Cholestatic Pruritus
Merck’s Subcutaneous Keytruda Shows Non-Inferiority in Phase 3 Trial, Paving Way for Regulatory Discussions
Merck, Keytruda, subcutaneous, cancer immunotherapy, phase 3 trial, non-inferiority, regulatory submissions