FDA
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
FEATURED STORIES
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The rejection comes about a month after the painkiller was cleared by an FDA advisory committee.
The U.S. Food and Drug Administration (FDA) has issued an approval letter for the new features and intended uses of the Planmed Verity® CBCT scanner. Planmed is very pleased to bring these exciting improvements to the U.S. market.
Late Thursday, Genentech said the U.S. Food and Drug Administration granted regulatory approval for a combination of Tecentriq and Avastin for treatment of some metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
A report from the Government Accountability Office said the FDA failed to live up to the legal requirements when approving drugs under a rare disease designation.
Florida-based Catalyst Pharma won regulatory approval for its treatment of a rare autoimmune disorder called Lambert-Eaton myasthenic syndrome (LEMS). The U.S. Food and Drug Administration approval of the new oral drug, Firdapse (amifampridine), is the first ever approved for this disease.
The FDA approved Xospata for adult AML patients who have a FLT3 mutation as detected by an FDA-approved test. Of the 19,000 people in the United States who are estimated to be diagnosed with AML this year, nearly 40 percent will have a FLT3 mutation.
The U.S. Food and Drug Administration (FDA) gave the green light late Monday to Bayer oncology drug Vitrakvi, a first-of-its-kind TRK inhibitor, after late-stage clinical trial results showed a 75 percent overall response rate and 22 percent complete response rate across various solid tumors.
The U.S. Food and Drug Administration will update its review process for the approval of medical devices in the wake of a report that showed more than 80,000 injuries have been associated with medical devices for pain management since 2008.
AbbVie could be eyeing another potential billion dollars of annual revenue following the accelerated approval of Venclexta for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or who cannot tolerate intensive chemotherapy.
The report, which was issued by the Council of Economic Advisors, pointed to changes in the approval process at the FDA in the approval process of generic drugs has led to greater competition in the marketplace, which has lowered the costs of the medications.