Qualitative Concept
Teva Pharmaceuticals Agrees to $450M Settlement Over Kickback and Price-Fixing Allegations
Teva Pharmaceuticals, False Claims Act, Anti-Kickback Statute, price-fixing, kickbacks, settlement, generic drugs, Medicare, Copaxone
FDA Approves Roche’s Itovebi, a PI3K Inhibitor for Advanced Breast Cancer Treatment
Roche, Itovebi, PI3K inhibitor, breast cancer, FDA approval, PIK3CA mutation, hormone receptor-positive, HER2-negative
FDA Delays Approval of Zealand Pharma’s Dasiglucagon for Congenital Hyperinsulinism Due to Third-Party Manufacturing Issues
Zealand Pharma, dasiglucagon, congenital hyperinsulinism, FDA, Complete Response Letter, third-party manufacturing issues
Basecamp Research Secures $60M to Revolutionize AI Drug Discovery with Broad Institute Partnership
AI drug discovery, Basecamp Research, Broad Institute, David R. Liu, Biotechnology, Gene therapy, Artificial intelligence in biology
FDA Raises Concerns Over Stealth BioTherapeutics’ Ultra-Rare Disease Drug Ahead of Advisory Committee Meeting
FDA, Stealth BioTherapeutics, elamipretide, Barth syndrome, ultra-rare disease, advisory committee meeting, drug approval, efficacy concerns
Zealand’s Hypoglycemia Drug Faces Second FDA Rejection Due to Manufacturing Issues
Zealand Pharma, FDA rejection, dasiglucagon, congenital hyperinsulinism, hypoglycemia, CDMO inspection
Biogen’s Higher Dose Spinraza Shows Enhanced Efficacy in Treating Spinal Muscular Atrophy
Biogen, Spinraza, Nusinersen, Spinal Muscular Atrophy (SMA), Higher Dose Regimen, Clinical Trial Results, DEVOTE Study, Motor Function Improvement, Neurodegeneration Reduction
FDA Raises Concerns Over Stealth BioTherapeutics’ Ultra-Rare Disease Drug Approval
Stealth BioTherapeutics, ultra-rare disease, FDA approval, Barth syndrome, elamipretide
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
Compounding Pharmacies Challenge FDA’s Decision to End Eli Lilly’s GLP-1 Drug Shortage
Eli Lilly, GLP-1 drug, FDA, compounding pharmacies, drug shortage, lawsuit