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The moment dietary supplement manufacturers start making specific curative claims, supplements are seen as drugs in the eyes of the FDA and require an IND, says a new guidance document. Read More
Drugmakers want the FDA to provide more details on how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More
The European Medicines Agency announced a new drug pathway program that promises earlier, more extensive support for drugmakers researching new priority therapies to increase chances of taking them to market. Read More
A recent study published in JAMA Oncology found that lower income levels were linked to reduced participation in clinical trials for experimental cancer drugs. The results reinforce earlier findings from the same team, indicating that the disparity may be a trend and not an anomaly. Read More
The Federal Court of Canada has quashed Health Canada’s import ban on drugs from two Apotex facilities in India, saying the agency proceeded unfairly. Read More
The FDA approved GlaxoSmithKline’s injectable drug Nucala Wednesday for use in patients 12 years and older suffering from severe asthma attacks. It is intended to be used in conjunction with other asthma drugs. Read More