A new drug application (NDA) has been submitted to the FDA for sunvozertinib in pretreated EGFR exon 20–positive advanced non ...

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

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

Multiple myeloma is the second most common hematologic malignancy, but there is a treatment gap for patients with disease ...

(AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that AB-1003 (also known as LION-101) has received rare pediatric disease ...

Merus expects the FDA to make a decision on the application in February after reviewing additional manufacturing information it submitted.

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

CA1 is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from the FDA ...

Ecstasy, also known by the pharmaceutical shorthand MDMA (an abbreviation of 3,4-methylenedioxymethamphetamine), is used illegally by millions in the U.S. The synthetic drug has been banned since ...

The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for tapinarof cream, 1% in the treatment of atopic dermatitis in adults and ...

Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims ...

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for donidalorsen for the prophylactic treatment of hereditary angioedema (HAE) in adults and pediatric patients aged ...