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A drug manufacturer in Bangalore, India, drew a warning letter from the FDA for failing to properly investigate contamination at its facility. Read More
The National Institutes of Health (NIH) said it plans to study an investigational antiviral from Gilead Sciences that proponents believe may offer significant advantages over remdesivir as a possible COVID-19 treatment. Read More
AstraZeneca has dosed the first participants in a phase 1 trial of its investigational monoclonal antibody product AZD7442 for preventing and treating COVID-19. Read More
The Trump administration’s Aug. 24 deadline has come and gone for the pharma industry to come up with a drug pricing strategy that would prevent a threatened executive order by President Trump from going into effect — but the White House and big pharma have remained silent. Read More
FDA Commissioner Stephen Hahn issued an apology Tuesday for the way he portrayed the effectiveness of convalescent plasma as a COVID-19 treatment during the announcement of the FDA’s Emergency Use Authorization (EUA) — but he stressed the independence of the agency in its regulatory decisions amidst concerns of political pressure. Read More
The FDA rapped an AbbVie manufacturing facility in Barceloneta, Puerto Rico, for good manufacturing practice failures, including missing written procedures. Read More
The FDA has turned down Tricida’s new drug application for veverimer (TRC101) as a treatment for metabolic acidosis in patients with chronic kidney disease and said it needs to see more supporting data. Read More