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 FDA has approved Agios Pharmaceuticals’ Pyrukynd for a rare type of hemolytic anemia treatment. Continue reading the article to know more about the new drug.
It’s not clear if the recent deaths reported in FAERS resulted from the patients taking Aduhelm. This article takes a deep dive into this controversy.
In April 2021, the U.S. Food and Drug Administration issued Acadia a Complete Response Letter (CRL) related to its previous attempt to expand the approved indication for Nuplazid.
The FDA will evaluate AMX0035, an investigational oral fixed-dose drug intended for people diagnosed with ALS.
The FDA committee voted 8 yes and 14 no. The decision now goes back to the OND to decide the FDDR on Avenue Therapeutics’ IV Tramadol.
The NDA acceptance is based on positive results from the KRYSTAL-1 trial, which looked into the effect of using 600mg BID of adagrasib in patients.
After announcing that the FDA was investigating a possible death associated with its lymphoma drug Ukoniq (umbralisib), things are seemingly looking up for TG Therapeutics.
Although the Omicron surge appears to be waning in the U.S., the World Health Organization keeps an eye on four Omicron subvariants.
Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
Shares of Cassava Sciences are up more than 5% in premarket trading after the FDA denied a Citizen Petition filed last year to suspend the company’s Alzheimer’s clinical trials.