Phase III
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
The FDA called for Iterum to conduct an additional clinical study that uses a different drug for comparison and to determine optimal dosing.
The FDA’s ODAC met to discuss retifanlimab and voted 13-4 that a regulatory decision for the drug for this indication should be deferred until more data was available.
Abeona Therapeutics’ shares popped 18.32% in pre-market trading after New York and Cleveland-based company announced magnetic resonance imaging (MRI) data from its Phase I/II Transpher A trial in San Filippo Syndrome Type A (MPS IIIA).
The company said its Allergan eye drops met both its primary and key secondary endpoints, with patients reporting near and intermediate improvements in vision.
The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
It was another busy week for clinical trial updates. Here’s a look at some including Mesoblast Limited, CytoDyn, Magenta Therapeutics and more.
The antibody is still being evaluated in clinical studies, with a large-scale Phase III trial expected to wrap in the second half of 2022.
The lawsuit alleges that Ocugen made “materially false and misleading statements” about its operations and compliance policies.
The recent survival results of Masitinib will help (ALS) patients to live longer. AB Science has successfully established the sweet spot for masitinib in ALS.
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