Regulatory
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.
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.
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.
The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.
Heading into the middle of January, companies announced plenty of new clinical trial news. Here’s a look.
Former Food and Drug Commissioner Robert Califf is one step closer to returning to his old office after the Senate Health, Education, Labor and Pensions Committee advanced his nomination.
Researchers from the Medical University of Bialystok in Poland identified a gene that appears to double the risk of severe COVID-19.
PCN-101 was recently awarded Investigational New Drug (IND) status by the U.S. Food and Drug Administration. It’s a for treating the patients with treatment resistant depression.
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