Sarepta Therapeutics announced Thursday that the U.S. Food and Drug Administration has put the Phase II trial of its Duchenne muscular dystrophy (DMD) candidate SRP-5051 (vesleteplirsen) on clinical hold following a serious safety signal.
The U.S. Food and Drug Administration released new draft guidance that addresses Breakthrough Therapy designation.
The Food and Drug Administration on Thursday blocked e-cigarette maker Juul Labs Inc. from selling its nicotine products in the United States, potentially dealing a fatal blow to the once high-flying San Francisco company.
Moderna Inc. said on Wednesday that an updated version of its COVID-19 vaccine designed to target the Omicron variant also generated a strong immune response against the fast-spreading Omicron subvariants BA.4 and BA.5, which have gained a foothold in the U.S. in recent weeks.
The U.S. Food and Drug Administration is preparing to order Juul Labs Inc. to take its e-cigarettes off the market in the United States, the Wall Street Journal reported on Wednesday, citing people familiar with the matter.
Merck scored another big win Wednesday with a U.S. Food and Drug Administration approval for an expanded indication of Vaxneuvance, its pneumococcal 15-valent conjugate vaccine. The new indication includes children 6 weeks through 17 years of age.
The Biden administration plans to propose a rule to establish a maximum nicotine level in cigarettes and other finished tobacco products in an attempt to make them less addictive, the White House Budget Office said Tuesday.
For years, PTC Therapeutics has attempted to win regulatory approval for its Duchenne Muscular Dystrophy drug, Translarna (ataluren), but time and time again, the U.S. Food and Drug Administration has rejected the attempts. Now, the company believes it has data that will support another filing for possible approval.
The rollout in the United States this week of COVID vaccines for children as young as six months is likely to start slowly, and then pick up in the coming days, according to White House COVID-19 response coordinator Ashish Jha.
The U.S. Food and Drug Administration has a handful of PDUFA dates over the next two weeks.