US FDA to hold off action on weight-loss drug copies pending court ruling
The U.S. Food and Drug Administration said on Monday it will not take action against compounding pharmacies making copies of ...
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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 ...
FDA cancels pivotal advisory meeting about next season's flu vaccine
An FDA vaccine advisory committee meeting to discuss next season’s flu vaccine has been canceled, potentially delaying the ...
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FDA Removes Hold on Duchenne Muscular Dystrophy Drug
Following a more than two-year-long hold, Entrada Therapeutics can get its Duchenne muscular dystrophy (DMD) candidate back on track. The company announced on Monday that the US Food and Drug ...
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FDA puts clinical hold on BioNTech’s malaria vaccine trial
The US Food and Drug Administration has put a clinical hold on BioNTech’s investigational new drug (IND) application and Phase I/II clinical trial examining the company’s pipeline malaria vaccine.
U.S. FDA places BioNTech's malaria vaccine study on clinical hold
BioNTech said in a regulatory filing on Tuesday the U.S. Food and Drug Administration has placed a clinical hold on an ...
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FDA removes clinical hold on Entrada’s Duchenne therapy
Entrada Therapeutics can plough on with the development of its Duchenne muscular dystrophy (DMD) therapy, ENTR-601-44, now that the US Food and Drug Administration (FDA) has lifted a two-year ...
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Atara, reeling from FDA hold on Ebvallo, lays off half of workforce
Atara revealed in January that the FDA has placed a clinical hold on the company’s investigational new drug applications for the Europe-approved Ebvallo in Epstein-Barr virus-positive post ...
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FDA Places Clinical Hold On BioNTech's Early-Phase Trial For RNA-Based Malaria Vaccine
The FDA placed a clinical hold on BioNTech’s Phase 1/2a trial for its investigational RNA-based malaria vaccine, BNT165e. BioNTech paused the study and is working with the FDA to address its ...
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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 clinical hold on BioNTech’s Investigational New Drug ...