The FDA has ordered BioNTech to immediately halt its Phase I/II trial of malaria vaccine candidate BNT165e, pending changes.
BioNTech said in a regulatory filing on Tuesday the U.S. Food and Drug Administration has placed a clinical hold on an ...
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC ...
BioNTech's malaria vaccine trial faces an FDA clinical hold. The company is addressing concerns and collaborating with ...
BioNTech SE (NASDAQ:BNTX) said on Tuesday, that the U.S. Food and Drug Administration informed of a clinical hold on the ...
BioNTech's early-to-mid stage trial of an experimental malaria vaccine has been put on a clinical hold by the U.S. Food and ...
BioNTech has paused an early-stage study of its experimental malaria vaccine after the FDA handed it a clinical hold, the ...
The FDA has placed a hold on BioNTech’s phase 1/2a trial, pausing the company’s efforts to develop a RNA-based vaccine for ...
In a regulatory filing, BioNTech (BNTX) disclosed that the U.S. Food and Drug Administration has informed BioNTech SE that it has placed a ...
The FDA’s clinical hold has prompted a cautious response from investors, reflecting the heightened regulatory scrutiny that BioNTech now faces. The company’s immediate focus will be on resolving the ...
The trial was to evaluate the safety and efficacy of the RNA-based vaccine called BNT165e for prevention of malaria caused by ...