Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

Labeling is based on the agency's thorough analysis of the new drug application (NDA) or biological license application. The labeling, or prescribing information, is thus subject to FDA ...

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 ...

In a complete response letter, the FDA cited minor deficiencies related to drug substance, product, manufacturing and ...

today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become ...

Excitement is building around a new weight loss drug, CagriSema, which is expected to surpass the effects of popular drugs ...

The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

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 ...

MB-108 shows activity and is well tolerated in recurrent glioblastoma, with preclinical data supporting its combination with ...

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 ...

today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®[1]), an agent for the imaging of glioma. The ...