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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
In a pair of recent lawsuits over proposed generics, Takeda has sued Apotex for allegedly infringing on its leukemia drug Iclusig (ponatinib) and Eli Lilly has filed suit against Dr. Reddy’s over alleged infringement of its osteoporosis therapy Forteo (teriparatide). Read More
As part of its commitments for reauthorization of its user fee programs, the FDA today officially launched a new initiative to help sponsors of new drug and biologics products incorporate real-world evidence (RWE) into their clinical trials. Read More
FDA Commissioner Robert Califf warned that the agency’s accelerated approval pathway is in dire need of reform during remarks at the 2022 National Organization for Rare Disorders (NORD) Breakthrough Summit held earlier this week. Read More