Phase II
The company said it will file a marketing application later this year for the drug under the FDA’s accelerated approval pathway.
The U.S. FDA has had a mix of announcements this week, from drug approvals to the acceptance of NDAs and INDs. Here’s a look.
Fulcrum achieved what the company is calling a clinical first. Data showed that using losmapimod slowed the progression of FSHD and demonstrated improved function in patients.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Roche presented results from several Phase II and III trials at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting held virtually June 19-22.
Spruce Biosciences shared results from two Phase II studies assessing tildacerfont, a non-steroidal, oral antagonist for the treatment of adult patients with classic CAH.
It was another busy week of clinical trial announcements. Here’s a look.
Eisai believes this is a potential-best in class FRα ADC that has shown single agent activity in patients with advanced solid tumors, including endometrial, ovarian, lung and breast cancers.
Biogen’s quest to develop additional medicines for Alzheimer’s disease beyond its newly-approved aducanumab has hit a clinical snag after gosuranemab failed.
Please check out the biopharma industry’s COVID-19 stories that are trending for June 15, 2021.
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