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The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the compound a priority review. Read More
In a low-key pre-holiday move, the FDA converted three alternative dosing regimens of Merck’s blockbuster cancer drug Keytruda from accelerated to full approval, a move that is not likely to be questioned by critics of the accelerated approval pathway due to the wealth of safety data behind the drug. Read More
The agency’s expanded approval was supported by results from a study, with 24 percent of participants having had at least one cancerous lesion detected. Read More