ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations for its lead candidate, ALX148, for the first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction (gastric/GEJ) carcinoma.
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
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