2024
FDA Places Clinical Hold on PepGen’s Duchenne Muscular Dystrophy Trial
FDA, Clinical Hold, PepGen, Duchenne Muscular Dystrophy, PGN-EDO51, CONNECT2-EDO51
Novo Nordisk Invests $1.2 Billion in New Danish Production Facility for Rare Disease Therapies
Novo Nordisk, rare disease drugs, Denmark, production facility, investment, hemophilia, pharmaceutical manufacturing
FDA Approves UNLOXCYT for Advanced Cutaneous Squamous Cell Carcinoma, Marking a New Era in Skin Cancer Treatment
UNLOXCYT, cosibelimab-ipdl, FDA approval, advanced cutaneous squamous cell carcinoma (cSCC), checkpoint inhibitor, immunotherapy, skin cancer treatment.
AbbVie Expands Immunology Pipeline with $200M Acquisition of Nimble Therapeutics
AbbVie, Nimble Therapeutics, Immunology, Psoriasis, Autoimmune Diseases, IL23R Inhibitor, Peptide Therapeutics
EMA Supports Approval of Gilead’s Liver Disease Drug from $4.3B CymaBay Acquisition
Gilead Sciences, CymaBay Therapeutics, seladelpar, primary biliary cholangitis (PBC), liver disease, EMA approval, $4.3 billion deal
EU Regulator Determines Mounjaro Effective for Sleep Apnea, No Separate Approval Required
Mounjaro, sleep apnea, EU regulator, European Medicines Agency (EMA), tirzepatide, weight loss, obesity
Advancements in ctDNA Testing for Early Detection of Breast Cancer Recurrence
ctDNA (circulating tumor DNA), Breast Cancer Recurrence, Early Detection, Liquid Biopsy, Whole Genome Sequencing, Molecular Residual Disease
Cancer Pipelines Contract: Incyte and iTeos Discontinue Drug Candidates Amid Underwhelming Clinical Results
Incyte, iTeos, cancer pipelines, drug candidates, clinical trials, disappointing data, pipeline cuts, oncology research.
Keros Therapeutics Halts Higher Dose Arms in PAH Trial Due to Pericardial Effusion Concerns
Keros Therapeutics, TROPOS trial, pulmonary arterial hypertension (PAH), cibotercept (KER-012), pericardial effusion, clinical trial safety
FDA Halts Pediatric RSV Vaccine Trials Due to Safety Concerns
RSV vaccines, pediatric trials, safety concerns, FDA hold, VAERD risk