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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Curis, a biotech company that develops treatments for cancer, has announced that the FDA has placed a partial clinical hold on its TakeAim lymphoma study.
The U.S. FDA greenlit China-based Triastek’s IND Application for its 3D printed drug product, T20, for cardiovascular and clotting disorders.
Alnylam Pharmaceuticals issued a proxy filing ahead of its May 18, 2022, Annual Meeting of Stockholders to inform stockholders of several items they can vote on at the end of the meeting.
The American Academy of Neurology Annual Meeting (AAN) was held virtually and in-person in Seattle from April 2-7. Here’s a look at some of the highlights.
With the accelerated approval from the U.S. Food and Drug Administration, Vijoice becomes the first treatment approved in the United States for PROS
The U.S. Food and Drug Administration (FDA) has approved BioXcel Therapeutics’ Igalmi, a drug designed to reduce agitation episodes in bipolar disorder and schizophrenia patients.
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the FDA’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture.
Kite Pharma, a subsidiary of Gilead, announced that its Yescarta® has been approved by the U.S. Food and Drug Administration (FDA).
The U.S. FDA placed a partial hold on CytoDyn’s HIV program and a full clinical hold on its COVID-19 program in the U.S.
Orchard Therapeutics announced today that it intends to focus its hematopoietic stem cell (HSC) gene therapy platform exclusively on severe neurometabolic diseases and early research programs.