The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

A D.C. drugmaker has been dealt a major setback in its long-running bid to bring its treatment for a chronic gastrointestinal ...

Based in part on these results, the company announced earlier this month that it had filed a new drug application for elinzanetant with the U.S. Food and Drug Administration. Advertisement ...

The Food and Drug Administration (FDA) has cleared an investigational new drug application for the novel treatment, APTN-101, ...

The results of the study, dubbed MAPP2, will support the submission of a new drug approval application expected from MAPS PBC in the third quarter of 2023. “The Phase 3 confirmatory results ...

The FDA recently approved Voquezna, the first potassium-competitive acid blocker drug for treating erosive and non-erosive ...

A constitutional challenge to the Biden administration program enabling Medicare to negotiate lower prices for prescription ...

The last decade has seen a “dramatic increase” in investigational new drug (IND) applications for cannabis-derived products, according to the U.S. Food and Drug Administration. In a paper ...

Rather than doing a protocol or a clinical trial and another clinical trial for a drug and then you disassemble the whole enterprise and you start over again for the next clinical trial.

BERLIN--(BUSINESS WIRE)--Bayer today announced that a New Drug Application (NDA) for the investigational compound elinzanetant has been submitted to the U.S. Food and Drug Administration (FDA ...

The market for weight-loss treatments is expected to see 16 new drugs vying for a slice of the lucrative business currently ...

today announced that the Company has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic solution) for the treatment of ...