The U.S. Food and Drug Administration placed a partial clinical hold on the TakeAim lymphoma study while the biotech company Curis provides further data to better understand safety and efficacy questions.
The Food and Drug Administration placed a partial hold on CytoDyn’s HIV program and a full clinical hold on the company’s COVID-19 program in the United States.
Cassava Sciences warned that the U.S. Food and Drug Administration might order a clinical hold on the company’s studies for the Alzheimer’s drug simufilam in 2022 after learning that two of its competitors received hold orders for similar research efforts.
BioMarin updated several of the company’s gene therapy programs on February 17 following a September 2021 update, when the drug manufacturer reported the U.S. Food and Drug Administration had placed a clinical hold on the BMN 307 Phearless Phase I/II trial.
Shares of LogicBio Therapeutics fell more than 57 percent on February 2 after the company announced that its gene therapy for pediatric patients with methylmalonic acidemia was placed on clinical hold by the U.S. Food and Drug Administration.
South San Francisco-based Cortexyme Inc. received a letter from the U.S. Food and Drug Administration on January 25 placing a full clinical hold on the Investigational New Drug application for the company’s lead clinical asset atuzaginstat, which is in development for the treatment of Alzheimer’s disease.
Gilead Combo Therapy Hit with FDA Hold Over Serious Adverse EventsAcute Myeloid Leukemia (AML), CD47 Protein, Clinical Trials, Combination Therapies, Diffuse large B-cell lymphoma (DLBCL), FDA/Regulatory, Gilead, Head & Neck Squamous Cell Carcinoma (HNSCC), Malignancies, Myelodysplastic Syndromes, Partial Clinical Hold, R&D, Triple Negative Breast Cancer (TNBC)
The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.
The U.S. Food and Drug Administration lifted the partial hold on Kura Oncology’s clinical trial on a potential treatment for acute myeloid leukemia (AML).
The U.S. Food and Drug Administration lifted the clinical hold made by the regulatory agency during February 2021 for Spero Therapeutics’ Phase IIa trial of SPR720, an oral antimicrobial agent being studied in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).
Shares of Kura Oncology plunged in trading on November 24 after the San Diego-based company announced the U.S. Food and Drug Administration placed a partial clinical hold on a Phase Ib leukemia study assessing KO-539 following the report of a patient’s death.