FDA
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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The extension will give the FDA sufficient time to look into the drug for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Monoclonal antibodies have proven to be an important therapeutic option in the ongoing battle against COVID-19.
Merck’s Keytruda (pembrolizumab) keeps expanding the indications for which it’s approved. The company announced today that the FDA had approved the anti-PD-1 therapy for adjuvant treatment of renal cell carcinoma.
The FDA and CDC will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization for the booster shot for their COVID-19 vaccine.
The research showed that 61% of patients with PV experienced a complete hematological response after 7.5 years of treatment with BESREMi. Here’s more about it.
Pfizer and BioNTech requested the FDA authorize booster shots for their COVID-19 vaccine for all adults 18 years and older, presenting data not available in September.
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.
Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.
Pfizer plans to seek Emergency Use Authorization for an antiviral COVID-19 treatment following an interim analysis of Phase II/III data that show statistically and clinically meaningful results.
This week, the U.S. Food and Drug Administration accepted Investigational New Drug Applications for multiple companies, clearing the way for clinical development.