The U.S. Food and Drug Administration said on Monday it will not take action against compounding pharmacies making copies of ...

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 ...

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 ...

An FDA vaccine advisory committee meeting to discuss next season’s flu vaccine has been canceled, potentially delaying the ...

BioNTech said in a regulatory filing on Tuesday the U.S. Food and Drug Administration has placed a clinical hold on an ...

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.

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 ...

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 ...

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 ...

In a regulatory filing, BioNTech (BNTX) disclosed that the U.S. Food and Drug Administration has informed BioNTech SE that it has placed a ...