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

A new report looks at hiring trends © 2025 American City Business Journals. All rights reserved. Use of and/or registration ...

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

Merck MRK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its investigational, once-daily, oral, two-drug, single-tablet regimen of ...

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

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. | ...

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 ...

On Dec. 12, 2023, MAPS PBC, now Lykos Therapeutics, announced their submission of a New Drug Application to the FDA for MDMA in combination with psychotherapy for the treatment of post-traumatic ...

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 ...

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 ...

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 ...