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News about "Christian Rommel"
EMA Confirms Asundexian MAA for Assessment in Secondary Prevention of Ischemic Stroke
The EMA has accepted the Marketing Authorisation Application (MAA) for asundexian, the first Factor XIa (FXIa) inhibitor under review in Europe for secondary prevention of ischemic stroke. The submission is supported by positive phase 3 OCEANIC-STROKE data.
Christian Rommel | 11/06/2026 | By News Bureau | 108
US FDA Grants Priority Review to HYRNUO for HER2-Mutated NSCLC
The US FDA has granted Priority Review (PR) to HYRNUO (sevabertinib) as a first-line treatment for HER2-mutated Non-Small Cell Lung Cancer (NSCLC), based on phase 1/2 SOHO-01 trial data.
Christian Rommel | 21/05/2026 | By News Bureau
FDA Grants Orphan Drug Status to BlueRock's OpCT-001
The ODD supports the clinical development of OpCT-001, the first iPSC-derived investigational cell therapy to enter human trials for Retinitis Pigmentosa (RP), a common inherited retinal disease marked by progressive loss of photoreceptor cells.
Christian Rommel | 23/01/2026 | By News Bureau | 304
Bayer Secures Breakthrough Status for Sevabertinib in HER2 NSCLC
US FDA and China’s CDE granted the designation for sevabertinib as a potential first-line therapy in advanced HER2-mutant non-small cell lung cancer.
Christian Rommel | 07/01/2026 | By News Bureau | 307
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