Gilead Sciences Inc. said on April 11 the U.S. Food and Drug Administration had lifted the partial clinical hold placed on the company’s trials testing a blood cancer drug combination.
The U.S. Food and Drug Administration placed a partial clinical hold on Alpine Immune Sciences’ NEON-2 trial, which is evaluating davoceticept (ALPN-202) in combination with Merck’s immunotherapy pembrolizumab (Keytruda) in adults with cancer.
The U.S. Food and Drug Administration placed a clinical hold on Gilead Sciences’ use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV and HIV pre-exposure prophylaxis (PrEP).
Shares of uniQure NV climbed after the company announced the clinical hold on its hemophilia B gene therapy was lifted by the U.S. Food and Drug Administration.
Shares of Solid Biosciences skyrocketed in trading after the company announced the U.S. Food and Drug Administration lifted the clinical hold on the IGNITE DMD Phase I/II clinical trial.
U.S. regulators halted a trial of Novartis’ Zolgensma treatment after an animal study raised safety concerns, in a setback for the drugmaker’s plan to expand the product’s use to older patients.
The U.S. Food and Drug Administration lifted a partial clinical hold placed on AbbVie’s Phase III CANOVA trial evaluating venetoclax for the treatment of relapsed/refractory multiple myeloma.
The U.S. Food and Drug Administration placed a partial clinical hold on all trials of AbbVie’s Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the cancer drug arm of the late-stage study.
The U.S. Food and Drug Administration placed Princeton, N.J.-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.
The U.S. Food and Drug Administration placed a clinical hold on an Investigational New Drug Application (IND) for Translate Bio’s rare liver disease treatment asset, MRT5201.