regulatory
European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment
Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions
AstraZeneca’s Airsupra Asthma Trial Halted Early Due to Overwhelming Efficacy, Paving Way for Regulatory Submission
AstraZeneca, Airsupra, asthma treatment, clinical trial, overwhelming efficacy, regulatory submission
BIOSECURE Act: A Potential Game-Changer for Biopharma – Industry Implications and Future Directions
BIOSECURE Act, Biopharma industry, US-China relations, Biotechnology collaborations, Supply chain diversification, Regulatory compliance
Moderna Faces Second Consecutive Marketing Breach for Spikevax Vaccine
Moderna, Spikevax, Marketing Breach, COVID-19 Vaccine, Regulatory Compliance
Japanese Regulators Approve Medications from Amgen, Eli Lilly, Takeda, and Nxera
Japanese regulators, medication approvals, Amgen, Eli Lilly, Takeda, Nxera, pharmaceutical industry, regulatory updates
Sanofi Prepares for Regulatory Submission of Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis
Tolebrutinib, BTK inhibitor, Multiple sclerosis, Non-relapsing secondary progressive multiple sclerosis (nrSPMS), Sanofi, HERCULES study, GEMINI 1 and 2 studies, Regulatory approval
FDA Enhances Transparency in Drug Review Process with Revised Document Structure
FDA, drug review process, transparency, document structure, regulatory oversight
FDA Updates Guidance to Combat Online Misinformation About Medical Products
FDA, online misinformation, medical products, guidance, regulatory clarity, public health
Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Paving Way for Regulatory Filings
Gilead Sciences, Lenacapavir, HIV Prevention, Twice-Yearly PrEP, Regulatory Filings, PURPOSE 2 Trial
Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Eyes 2025 Launch for HIV Prevention
Lenacapavir, HIV Prevention, Twice-Yearly Injection, Gilead Sciences, PrEP, PURPOSE 1 and 2 Trials, Regulatory Filings, 2025 Launch