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.
FEATURED STORIES
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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 FDA is threatening Acceleron with a $10,000 fine or criminal prosecution, charging the company with failure to post a summary of study data on its cancer combo dalantercept and axitinib in the ClinicalTrials.gov online database.
Moderna, one of three companies to have a COVID-19 vaccine authorized in the U.S., isn’t resting on its accomplishments but is instead working to scale up production further and improve on its vaccine.
Texas is quickly becoming a hotbed of biopharmaceutical activities, with Houston being one of the two top cities in the state that is leading the way.
A U.S. FDA committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with mTNBC.
Takeda’s non-small cell lung cancer treatment Mobocertinib is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
Top-line results from the Phase III INVIGORATE trial show Aldeyra Therapeutics’, reproxalap, significantly reduced ocular itching in patients with allergic conjunctivitis.
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.