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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
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
President Biden signed into law a $1.7 trillion omnibus spending package on Dec. 23, appropriating $3.5 billion in discretionary funding for the FDA through Sept. 30, 2023 — an increase of $226 million, or 6.5 percent, from what was enacted for the agency in 2022. Read More
Amgen has become the latest drugmaker to file a lawsuit against HHS over the federal government’s attempts to force pharma companies to provide 340B drug discounts to contract pharmacies. Read More
Biogen and Eisai’s lecanemab — the antiamyloid antibody that recently posted the best-ever Alzheimer’s disease (AD) phase 3 data — shouldn’t cost more than $20,600 per year to be considered a cost-effective therapy for the disease, according to a new draft analysis by the Institute for Clinical and Economic Review (ICER). Read More