For full approval, the FDA has at least six months of efficacy data to review – and that means combing through and analyzing an enormous amount of information.

To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) and to expand the indication of ...

The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the ...

Two vaccine makers have now started the process for full FDA approval. One-third of unvaccinated U.S. adults say they will only get in line for the COVID-19 jab once it's fully approved ...

granted full regulatory approval anywhere in the world — marks a pivotal advance. The new vaccine platform could provide potent defence against various infectious diseases and cancers.

By Sharon LaFraniere and Noah Weiland WASHINGTON — The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older ...

While the previous PATHFINDER study—a prospective, year-long examination of about 6,600 people—showed that Galleri could more ...

is correct that the clinical trials that gave rise to the emergency authorizations “were as rigorous as those for full approval,” but that’s far from the whole story. The history of drug and ...

It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups. The FDA recently asked ...

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to ...