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 by doctors experienced in the treatment of cancer.
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). Hetronifly should be prescribed and supervised by doctors experienced in the treatment of cancer.
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 (Hetronifly; Hansizhuang in China) for...
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.
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 market after BeiGene’s Tevimbra, CStone’s Cejemly and Shanghai Junshi’s Loqtorzi.
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 with Extensive-Stage Small Cell...
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 lung cancer (SCLC).
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* (marstacimab), received a positive opinion for the treatment of bleeding episodes in patients aged 12 years and older with severe haemophilia A or B, two types of a rare inherited ...
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 prescribed and supervised by doctors experienced in the treatment of cancer.
Orphans Elahere, Hetronifly & Hympavzi Among Eight New …
Sep 20, 2024 · Orphans Elahere, Hetronifly & Hympavzi Among Eight New Products Set For EU Approval. The European Medicines Agency has recommended the pan-EU approval of three rare disease drugs: Pfizer’s Hympavzi, Henlius Biotech’s Hetronify and ImmunoGen’s Elahere in addition to five other new medicines.
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