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.

This month, Neuvivo submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for NP001 (sodium chlorite infusion). The drug has been granted orphan drug and fast track ...

Despite the promise against cancer shown by the anti-malarial drug hydroxychloroquine, clinical trials have proved ...

The path from a scientist’s initial idea to a new medicine that can save lives is a complex and often lengthy process. It ...

The FDA has accepted a new drug application for the glioma-imaging agent Pixclara, with a decision expected next year. The Food and Drug Administration (FDA) has accepted a new drug application for ...

So, in no way do I think that the FDA is an easier place for companies to send their drug applications,” says Eric Schmidt, Biotechnology Equity Research Analyst, Cowen and Company, New York ...

acceptance of the New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low ...

Oct. 14, 2024 – A new breast cancer drug has received quick federal approval after a clinical trial showed it could more than double the time before a common type of breast cancer recurrence ...

It has a key role in the development of new drugs, which are evaluated for potential toxic effects in preclinical studies, clinical trials and post-marketing studies with the aim of ensuring that ...

A drug against fungal infections in cancer patients can last twice as long in people with obesity, and may make chemotherapy ...

“This new data shows there is hope, there is progress, and there is an urgent call to action for us all to continue working together across all of society to reduce drug overdose deaths and save ...

It broke open a market that could reach $130 billion by 2030 and has a cultural reach broader than any new drug since Viagra. Yet to keep its lead in the red-hot field of obesity, Novo must prove ...