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The FDA handed Granules Pharmaceuticals’ Chantilly, Va., drug manufacturing facility a six-observation Form 483 for deficient quality control procedures and other production lapses following a July 18 to July 22 inspection. Read More
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
NICE is not recommending Enhertu for routine National Health Service use because a clinical trial is ongoing, making the cost-effectiveness estimates very uncertain. Read More