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 ...

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic ...

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 U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...

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

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