EMA Recommends Granting a Marketing Authorisation for …
Oct 21, 2024 · Hetronifly in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with ES-SCLC. Hetronifly should be prescribed and supervised …
Hetronifly | European Medicines Agency (EMA)
Sep 19, 2024 · Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC). …
Europe Recommends Lung Cancer Drug Hetronifly - Medscape
Sep 20, 2024 · Hetronifly in combination with chemotherapy was shown to improve survival of patients with extensive stage small cell lung cancer, the European Medicines Agency said.
First-Line Serplulimab Receives Positive CHMP Opinion for ES-SCLC
Sep 23, 2024 · The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of serplulimab …
Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY ...
Sep 21, 2024 · Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY® (approved as HANSIZHUANG in China) in European markets as First-Line Treatment for adult patients …
The EU door to China-based approvals is open
Sep 23, 2024 · This followed the EMA’s validation of the filing in March, and will see serplulimab, to be trademarked Hetronifly, become the fourth China-originated anti-PD-(L)1 to enter the EU …
Hetronifly in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Hetronifly should be …
Hetronifly set to strengthen Accord’s EU injectable oncology …
Sep 23, 2024 · Hetronifly has been granted orphan drug status designation by the US Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of small cell …
Meeting highlights from the Committee for Medicinal Products for …
Sep 19, 2024 · The committee recommended granting a marketing authorisation for Hetronifly* (serplulimab), for the treatment of extensive-stage small cell lung cancer. Hympavzi* …
Orphans Elahere, Hetronifly & Hympavzi Among Eight New …
Jan 26, 2023 · Orphans Elahere, Hetronifly & Hympavzi Among Eight New Products Set For EU Approval. The European Medicines Agency has recommended the pan-EU approval of three …