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FDA Accepts Organon’s Application for Prolia Biosimilar
Regulators are also reviewing Teva’s application for its Prolia biosimilar candidate. The FDA’s decisions are expected mid-year 2025.
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FDA Accepts Resubmission of Translarna NDA for Duchenne
PTC Therapeutics' NDA resubmission of Translarna was based on data from Study 041 and the long-term STRIDE registry. No PDUFA action date was provided for regulators.
Biologics License Application Resubmitted for Prademagene Zamikeracel
Prademagene zamikeracel (pz-cel) could be a new treatment for rare genetic disease recessive dystrophic epidermolysis bullosa (RDEB).
GoodRx Offers Weight Loss Drug Qsymia for $149 at Retail Pharmacies
Qsymia’s manufacturer also released postmarketing data showing the oral therapy for weight loss was associated with reductions in 24-hour mean systolic blood pressure.
Rigel Warns Physicians About Fatal Infections from Gavreto
Gavreto used to treat metastatic RET fusion-positive non-small cell lung cancer and RET fusion-positive thyroid cancer.
FDA Approves IV Form of Stelara Biosimilar Selardsi
This week’s approval expands Seldardsi indications to treat adults with Crohn’s disease and ulcerative colitis.