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FDA Issues Draft Guidance on Integrating Clinical Trials into Routine Clinical Practice and Enhancing Diversity in Clinical Studies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
Boehringer Ingelheim Prepares NDA Filing for Pulmonary Fibrosis Drug After Positive Phase 3 Results
Boehringer Ingelheim, pulmonary fibrosis, NDA filing, Phase 3 data, nerandomilast, idiopathic pulmonary fibrosis (IPF)
Pfizer’s Next Challenge: Phase 3 Trials for Breakthrough Cancer Therapies
Pfizer, Phase 3 trials, cancer therapies, oncology pipeline, clinical trials
FDA Approves Lilly’s Ebglyss for Moderate-to-Severe Atopic Dermatitis
Ebglyss, atopic dermatitis, eczema, FDA approval, Eli Lilly, lebrikizumab, biologic treatment
Lantheus’ Phase 3 SPLASH Trial Results: 177Lu-PNT2002 Shows Promise but May Not Overtake Pluvicto
Lantheus, Phase 3 SPLASH Trial, 177Lu-PNT2002, PSMA-positive metastatic castration-resistant prostate cancer, ESMO Congress 2024, Pluvicto