Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

Researchers are building on the success of CAR T therapy in blood cancers to explore its use in clear cell renal cell ...

Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel ...

The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's drug ...

Johnson & Johnson (JNJ) gets FDA priority review for TAR-200 gains, a drug releasing system targeting bladder cancer. Read ...

The president's proposed budget cuts to the NIH would eventually result in fewer drugs on the market, the U.S. Congressional ...

The FDA prioritizes TAR-200 for treating high-risk bladder cancer, showcasing promising phase 2b study results and innovative ...

The FDA has accepted the New Drug Application for doravirine/islatravir for adults with virologically-suppressed HIV-1 infection.

Supporters believe that FDA approval will make the drug more accessible. Right now, traditional psilocybin therapy offered at healing centers in the state is not covered by insurance.