Henlius Reports NMPA NDA Acceptance of 120mg (1.7mL) per Vial Strength of HLX14 (Biosimilar, Denosumab)

Shots: The NMPA has accepted NDA for HLX14, a biosimilar version of denosumab, in the 120mg (1.7mL) per vial strength presentation NDA was based on extensive data, incl. analytical similarity studies, non-clinical & clinical comparative studies, where HLX14 at the 120 mg (1.7 mL) per vial strength showed similarity to its reference drug in terms…

ByRidhi RastogiSeptember 11, 2026

Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging

Shots: The US FDA has accepted the resubmitted NDA for TLX101-Px (Pixclara; 18F-FET), an investigational PET imaging agent for the detection and characterization of glioma in adult and pediatric patients The US FDA has assigned a PDUFA date of 11’Sep, 2026; TLX101-Px has received Orphan Drug and Fast Track designations, addressing unmet needs in distinguishing…

ByPrince GiriApril 10, 2026

The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer

Shots: The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…

ByDipanshu DixitFebruary 20, 2026

Henlius Reports NMPA NDA Acceptance of 120mg (1.7mL) per Vial Strength of HLX14 (Biosimilar, Denosumab)

Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging

The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer

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