FDA
New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.
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BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
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Enzyvant has resubmitted its Biologics Licensing Application to the U.S. FDA for its tissue-based regenerative pediatric congenital athymia therapy RVT-802.
There is hope for uniQure’s HOPE-B trial after all. Shares of uniQure NV are climbing this morning after the company announced the clinical hold on its hemophilia B gene therapy has been lifted by the U.S. Food and Drug Administration.
The approval was specifically for patients with recurrent or advanced endometrial cancer who had progressed on or after previous treatment with platinum-based chemotherapy and whose cancers have a dMMR genetic anomaly.
Amgen announced the U.S. FDA awarded Breakthrough Therapy Designation to the bemarituzumab as a first-line treatment for certain types of gastric cancer.
Opdivo, the trade name for the generic Nivolumab, can now be used in combination with certain types of chemotherapy for initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
The reason for the request was the monotherapy antibody therapy is less effective against the COVID-19 variants, such as have risen from the U.K., South Africa and Brazil, as well as the growing B.1.427/B.1.429 California variant.
The approval marks the second approval for Trodelvy, which Gilead gained through its $21 billion acquisition of Immunomedics.
On Tuesday, Celularity received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its off-the-shelf natural killer cell therapy for malignant gliomas.
The U.S. Food and Drug Administration (FDA) granted vTv Therapeutics’ TTP399 Breakthrough Therapy designation for type 1 diabetes. This designation provides companies more support and the possibility of shorter development and review timelines.
The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company.