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The trial is scheduled to commence in the fourth quarter of this year, with subject recruitment in both Europe and the US.

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug ...

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

Johnson & Johnson (NYSE:JNJ) submitted a supplemental New Drug Application for CAPLYTA®, aiming to prevent schizophrenia ...

Arcus Biosciences announced that the Food and Drug Administration has granted its pancreatic cancer treatment, quemliclustat, with an orphan drug designation. The company said it expects its ongoing ...

After promising results from separate Phase 2 and 3 trials, Cidara Therapeutics has submitted a new drug application to the US Food and Drug Administration (FDA) for the compound rezafungin, for ...

Novo Nordisk NOVO.B0.48%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...

Understanding an Abbreviated New Drug Applications . A company that intends to market a generic drug needs to show the FDA that the drug has been found to be bioequivalent, which means that it can ...

A drug under development could provide a much needed option for women seeking relief from hot flashes and other menopausal symptoms, new research shows. Top News U.S. News ...