March 27th 2024
Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.
FDA Approves Adzynma for Congenital Thrombotic Thrombocytopenic Purpura
November 9th 2023Adzynma was previously granted a FDA Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations for patients with congenital thrombotic thrombocytopenic purpura.
FDA Restricts Keytruda Approval for Certain Patients With Gastric Cancer
November 9th 2023The FDA granted accelerated approved in May 2021 to pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
FDA Approves Expanded Indication for Abatacept to Treat Juvenile Psoriatic Arthritis
November 1st 2023Abatacept is indicated across multiple inflammatory conditions, including for the treatment of adult patients with moderately to severely active rheumatoid arthritis, pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis, and active juvenile psoriatic arthritis.
FDA Approves Interchangeable Ustekinumab Biosimilar for Inflammatory Diseases
November 1st 2023The FDA granted Wezlana with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions across multiple inflammatory diseases.
FDA Approves Keytruda Plus Chemotherapy for Biliary Tract Cancer
November 1st 2023The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.
Pushing Late-Stage Treatments Forward in the Clinic
September 17th 2020Shawn Singh, Chief Executive Officer of VistaGen Therapeutics, discusses the company's ongoing efforts to treat and help manage the anxiety symptoms related to the triggers and anxiety-related disorders COVID-19 provokes, and the FDA’s consensus on the design of their pivotal Phase III study of PH94B.