The greenlight for Journavx (suzetrigine), which comes on the heels of a $7.4 billion opioid settlement, could spark momentum ...

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation (RPDD) to Arbor Biotechnologies' gene editing therapeutic, ABO-101, to treat ...

The U.S. Food and Drug Administration (FDA) approved Thursday a new type of prescription pain medication for moderate to ...

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.

Vanda Pharmaceuticals Inc. recently made a significant move by filing a new drug application for Tradipitant. The application, targeted at addressing motion sickness, was publicized through a social ...

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...

The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response in patients with Bacillus Calmette-Guérin-unresponsive ...

GSK (GSK) announced that new drug applications have been accepted for review by the China National Medical Products Administration and submitted to the Japanese Ministry of Health, Labour and ...

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and ...

Celltrion launches ADC cancer drug trials in U.S. while planning additional INDs Celltrion accelerates its global drug ...