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 ...

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 ...

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 ...

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

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 ...

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 ...

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 ...

Meth. Clin. Dev. 19, 387–397; 2020). We also looked at whether approvals for the dCGTs included in this analysis received full traditional FDA approval or accelerated approval. For the approved ...

This decision came after the full FDA approval of YUTREPIA inhalation powder for adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.