Anticholinergic approved for COPD
FDA Grants Full Approval to Rybrevant in Lung Cancer
Rybrevant is indicated to be used in combination with chemotherapy as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer.
FDA Sets Action Date for Axatilimab in Graft-Versus-Host Disease
The Prescription Drug User Fee Act action date is Aug. 28, 2024.
FDA Sets Review Date for Tislelizumab in Stomach Cancer
The FDA has set an action in December 2024 for tislelizumab — now with the brand name Tevimbra — for metastatic gastric or gastroesophageal junction cancers.
FDA Grants Priority Review for Second Epkinly Indication
The FDA is reviewing Epkinly to treat relapsed or refractory follicular lymphoma. The target date is in August 2023.
FDA Expands Indication for Biktarvy for Those with Resistant HIV
Biktarvy can now be used to treat people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.
FDA Approves Simlandi, Third Interchangeable Humira Biosimilar
At the moment, Simlandi (adalimumab-ryvk) has the high-concentration, citrate-free, interchangeable Humira (adalimumab) market to itself.
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