Regulatory
The FDA raised doubts about the future of Ardelyx’s experimental chronic kidney disease drug tenapanor in briefing documents released ahead of a Wednesday advisory committee meeting.
During its third-quarter earnings call Monday, BrainStorm Cell Therapeutics emphasized its commitment to seek an advisory committee meeting for NurOwn in ALS.
BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against the potential Emergency Use Authorization of the company’s COVID-19 therapeutic candidate, sabizabulin.
A gene therapy being developed by Eikonoklastes Therapeutics to treat ALS received Orphan Drug Designation, the company announced Wednesday.
Ipsen will seek a new approval for Onivyde as a treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) after posting positive Phase III progression survival data.
The FDA deemed AstraZeneca’s PT027 to have a favorable risk-benefit profile for treating asthma in patients aged 18 or older but was less keen on supporting the drug in younger populations.
The FDA presented briefing documents Monday outlining what it called “uncertainties” in the data presented by Veru regarding its COVID-19 antiviral. An advisory committee will meet Wednesday.
Verve Therapeutics’ base editing program has been forced into a detour after the FDA placed a hold on its investigational new drug application. Beam has also posted its own regulatory update.
Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.
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