April 26th 2024
Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.
FDA Approves Takeda's Gammagard Liquid for Chronic Inflammatory Demyelinating Polyneuropathy
January 30th 2024This is Takeda's second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against relapse of neuromuscular disability and impairment in this patient population.
FDA Urges Caution Following Boxed Warning Requirements on CAR T-Cell Therapies
January 25th 2024FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.
FDA Issues Complete Response Letter to Theratechnologies sBLA for New Formulation of Tesamorelin
January 25th 2024Theratechnologies said it will address the FDA’s complete response letter and will continue to seek approval for the new formulation of tesamorelin for the treatment of lipodystrophy in patients also diagnosed with HIV.
FDA Issues Complete Response Letter to Astellas for Zolbetuximab BLA for GEJ Adenocarcinoma
January 9th 2024The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
FDA Grants Priority Review to Pfizer and Genmab's Tivdak for Cervical Cancer Treatment
January 9th 2024Supplemental Biologics License Application would convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) to a full approval for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy
November 29th 2023The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.
Concerns Raised Over False Claims in Direct-to-Consumer Online Marketing of Ketamine
November 8th 2023The online promotion of intravenous infusions and oral forms of subanesthetic ketamine for the treatment of mental health conditions has been found to frequently carry misleading or false information.
Q&A with Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk
October 25th 2023Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk, shares her insights on fostering collaboration, embracing change, and her compelling vision to revolutionize digital transformation and innovation in the field of healthcare.