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

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.

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

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

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

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 ...

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 ...

for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. The deficiencies cited in the CRL are ...

has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®[1]), an agent for the imaging of glioma. The application has been granted priority review and designated a PDUFA[2] goal date ...

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