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At the request of sponsor Biogen, the FDA has extended by three months the new drug application review period for tofersen, an investigational treatment for SOD1 amyotrophic lateral sclerosis — a very rare genetically induced form of the fatal disease. Read More
The FDA will keep in place its regulations on orphan drug exclusivity rather than altering them in response to a pivotal U.S. appeals court ruling. Read More
The most likely cost-effectiveness estimates for the Ninlaro treatment combination is below $38,000 per quality-adjusted life-year, NICE said. Read More
In response to record high demand for ibuprofen oral suspension products, the FDA has issued an immediately-in-effect guidance allowing the products to be compounded in outsourcing facilities for use in hospitals and health systems. Read More
The FDA has finalized guidance on trials of human drugs containing cannabis and cannabis-derived compounds, offering updated direction on federally authorized sources for cannabis and providing references to relevant quality considerations. Read More
The FDA wants to annualize COVID-19 vaccination with a bivalent vaccine active against the original Wuhan strain plus two Omicron variants (BA.4 and BA.5). Read More
Rep. Frank Pallone, Jr. (D-N.J.) is pressing the FDA and NIH on their efforts to ensure ClinicalTrials.gov reporting requirements are followed, referencing recent findings in a letter to the agency chiefs that show significant sponsor compliance issues. Read More
Now is the time to overhaul drug development’s evidence generation system, wrote FDA Commissioner Robert Califf in the journal Clinical Trials. Read More
The FDA’s collaboration with the U.S. Patent Trade Office (USPTO) to bring down barriers that delay generics is off to a good start, according to FDA Commissioner Robert Califf, who points to drug companies’ “gaming tactics” as a major problem. Read More