Regulation or Law
Mass Firings at FDA Spark Concerns Over Agency’s Future
FDA, layoffs, leadership changes, public health, drug regulation, Trump administration
Biotech Restructuring and European Regulatory Setbacks
LifeMine Therapeutics, layoffs, PTC Therapeutics, Translarna, Duchenne muscular dystrophy, European Commission, regulatory decision
Incyte’s oral HS drug hits study goals, but fails to excite investors
povorcitinib, JAK1 inhibitor, hidradenitis suppurativa, Phase 3 trials, efficacy, investor reaction, regulatory submission
FDA Pauses BioNTech’s Malaria Vaccine Trial Amid Regulatory Scrutiny
BioNTech, malaria vaccine, FDA clinical hold, RNA vaccine, regulatory challenges
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
Robert F. Kennedy Jr. Confirmed as HHS Secretary in Close Senate Vote
RFK Jr., HHS Secretary, Senate confirmation, Trump administration, vaccine skepticism, healthcare policy, Make America Healthy Again
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