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The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for its New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough.
FDA rejected OPKO’s once-weekly human growth hormone, somatrogon, which it co-developed with Pfizer for the treatment of growth hormone deficiency (GHD) in pediatric patients.
Suliman anticipates filing an Investigational New Drug application with the FDA for the PCD asset this year, and next year filing one for the cystic fibrosis asset.
TScan Therapeutics, Lyell, SQZ Biotech and others secured clearance from the U.S. Food and Drug Administration for their Investigational New Drug Application.
It’s a landmark no one expected or wanted — more than 70 million confirmed COVID-19 cases in the U.S. with 866,000 deaths. For that and more COVID-19 news, continue reading.
Last week was a relatively quiet week for clinical trial news, particularly around COVID-19. Here’s a look.
The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).
Gilead has announced they are pulling cancer drug Zydelig (idelalisib) off the market for certain types of cancer after failing to complete follow-up clinical trials to confirm efficacy and safety.
The San Diego-based immunology company is locating and developing molecules where the mechanism of action has either been proven or makes sense.
After decades of treating the big categories of heart disease – hypertension, for example – the ability to address the genetics of heart disease is within sight.
January has been a largely quiet month for PDUFA dates on the U.S. Food and Drug Administration (FDA)’s calendar. There were two dates for the entire month, and one of those has been moved back to April. Here’s a look.
Pazdur, along with the FDA’s R. Angelo de Claro and Gautam Mehta from the Center for Drug Evaluation and Research, penned an opinion piece published Thursday in JAMA Oncology.