BioNTech, malaria vaccine and FDA

FDA puts clinical hold on BioNTech’s malaria vaccine trial
The FDA has ordered BioNTech to immediately halt its Phase I/II trial of malaria vaccine candidate BNT165e, pending changes.
U.S. FDA places clinical hold on BioNTech's malaria vaccine study
BioNTech said in a regulatory filing on Tuesday the U.S. Food and Drug Administration has placed a clinical hold on an early-to-mid stage trial of its malaria vaccine.
FDA Pauses Study of BioNTech’s Malaria Shot as Problems for Vaccine Space Mount
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
FDA Places Clinical Hold On BioNTech's Early-Phase Trial For RNA-Based Malaria Vaccine
BioNTech's malaria vaccine trial faces an FDA clinical hold. The company is addressing concerns and collaborating with regulators on next steps.
BioNTech malaria vaccine study placed on clinical hold by USFDA
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 Drug Administration (USFDA), the drugmaker said in a filing.The trial
BioNTech SE's RNA-based vaccine for malaria placed on clinical hold by FDA
BioNTech SE (NASDAQ:BNTX) said on Tuesday, that the U.S. Food and Drug Administration informed of a clinical hold on the company's Investigational New Drug application and mid-stage trial evaluating its vaccine for prevention of P.
BioNTech's RNA malaria vaccine trial hit by FDA hold
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 malaria prevention. | The FDA has placed a hold on BioNTech’s phase 1/2a trial,
FDA puts BioN­Tech’s malar­ia vac­cine on clin­i­cal hold
BioNTech has paused an early-stage study of its experimental malaria vaccine after the FDA handed it a clinical hold, the biotech disclosed Tuesday in a securities filing.
BioNTech reports FDA clinical hold on Phase I/IIa trial of BNT165e
In a regulatory filing, BioNTech (BNTX) disclosed that the U.S. Food and Drug Administration has informed BioNTech SE that it has placed a
BioNTech stock falls after FDA clinical hold on malaria vaccine trial
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 FDA’s concerns to resume the trial, which is a crucial step in the vaccine’s development process.
Yahoo Finance1mon
BioNTech Completes Acquisition of Biotheus
Acquisition to strengthen key pillar of BioNTech’s oncology strategy aimed at establishing BNT327 as a pan-tumor technology platform for the treatment of advanced cancers With the closing of the ...
Deccan Herald1d
US FDA places BioNTech's malaria vaccine study on clinical hold
The trial was to evaluate the safety and efficacy of the RNA-based vaccine called BNT165e for prevention of malaria caused by ...