PharmaMar, Jazz get FDA priority review for lurbinectedin in relapsed SCLC
As per the new drug application (NDA) for lurbinectedin, which has been accepted for filing by the regulator, the two companies are seeking accelerated approval for its use
Disc Medicine has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning its new drug application (NDA) for bitopertin for erythropoietic protoporphyria (EPP).
With the FDA’s approval, Voltaren Arthritis Pain becomes the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the United States.
Results presented at The European Crohn’s and Colitis Organisation (ECCO) 2020 annual congress in Vienna, Austria demonstrated that the SC formulation of CT-P13 was comparable to the IV
Intestinal ultrasound (IUS) responses were assessed and were detected as early as week 4.2 Week 16 data (digital oral presentation or DOP 13) and IUS response data (DOP
This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 17, 2020. “There remains a critical need for additional therapies in large B-cell