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The Centers for Medicare and Medicaid Services (CMS) should require clinical trial participation of patients seeking coverage for many new drugs, particularly those that have accelerated approval. Read More
The Health Resources & Services Administration (HRSA) has warned Merck that it could get slapped with fines for refusing to grant 340B discounts to hospitals and clinics that participate in the program. Read More
The FDA spelled out its latest thinking on demonstrating bioequivalence for topical generic drugs in four separate draft guidances released on Friday. Read More
The FDA has granted Regeneron an additional six months of pediatric exclusivity for its intraocular injection Eylea (aflibercept) as a treatment for preterm infants with retinopathy of prematurity (ROP). Read More
The FDA says it will push back its deadline for enforcing a statute that limits a compounding pharmacy’s out-of-state sales to 5 percent of its business if its state has agreed to take on oversight of interstate distribution of compound drugs. Read More
Both clinical and surrogate endpoints are acceptable targets for trials investigating gene therapies (GT) for neurodegenerative diseases, according to finalized FDA guidance on developing these products. Read More
The company is recruiting patients in three phase 1/2 clinical trials to investigate the efficacy and safety of ARTEMIS T cells, including one pediatric study evaluating ET140203. Read More