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.
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.
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.
Novartis will launch a new phase three study to expand the use of Zolgensma – the world’s most expensive one-time therapy at $2.1 million per patient treatment – after the U.S. regulator lifted its restrictions.
Regeneron Pharmaceuticals said on May 17 the company was resuming the enrollment of patients in two studies testing the experimental lymphoma drug odronextamab after the U.S. Food and Drug Administration agreed to lift a partial clinical hold.
Shares of Inovio Pharmaceuticals plunged in trading after the company reported the U.S. Food and Drug Administration placed a partial clinical hold on the planned Phase II/III study of the Covid-19 vaccine candidate INO-4800.
Ipsen decided to temporarily pause dosing in the company’s palovarotene extension studies for patients with fibrodysplasia ossificans progressiva following a recommendation from an Independent Data Monitoring Committee.