September 2024
FDA Approves Keytruda for First-Line Treatment of Malignant Pleural Mesothelioma
Keytruda, FDA approval, malignant pleural mesothelioma, MPM, first-line treatment, chemotherapy, pembrolizumab
FDA Enhances Transparency in Drug Review Process with Revised Document Structure
FDA, drug review process, transparency, document structure, regulatory oversight
Capricor Secures $35M Deal for European Rights to DMD Therapy Ahead of FDA Application
Capricor Therapeutics, Duchenne muscular dystrophy (DMD), cell therapy, FDA application, European rights, $35M deal
Nura Bio Secures $68 Million Funding for Neuroprotective SARM1 Inhibitor Development
Nura Bio, neuroprotective SARM1 inhibitor, $68M funding, pharmaceutical development, neuroprotection
Coherus Biosciences Addresses Temporary UDENYCA Supply Interruption
UDENYCA, Coherus Biosciences, supply interruption, biosimilar, pegfilgrastim, Neulasta, cancer treatment, white blood cell count, pharmaceutical supply chain.
Novartis’ Kisqali Secures Broad FDA Approval for Adjuvant Treatment of Early Breast Cancer
Kisqali, Novartis, FDA Approval, Early Breast Cancer, Adjuvant Treatment, HR+/HER2- Breast Cancer, CDK4/6 Inhibitors
CDMO Serán Secures $200M Investment from Bain Capital to Establish First Commercial Facility
CDMO Serán, Bain Capital, commercial facility, biopharmaceutical manufacturing, investment
FDA Issues Draft Guidance on Integrating Clinical Trials into Routine Clinical Practice and Enhancing Diversity in Clinical Studies
FDA, clinical trials, diversity, routine clinical practice, decentralized clinical trials, underrepresented populations, FDORA
Cigna’s Express Scripts Files Lawsuit Against FTC Over Allegedly Biased PBM Report
Express Scripts, FTC, PBM Report, Lawsuit, Biased, Erroneous, Drug Prices, Healthcare
FDA Updates Guidance to Combat Online Misinformation About Medical Products
FDA, online misinformation, medical products, guidance, regulatory clarity, public health