Page 93 - Human Use News Today

EQS-Ad-hoc: PAION AG / Key word(s): Miscellaneous PAION receives positive CHMP opinion recommending approval of remimazolam for the induc...

PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for Dupixent

ORION CORPORATION PRESS RELEASE 27 January 2023 at 14:00 EET Positive CHMP opinion for darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive

PAION AG / Key word(s): MiscellaneousPAION receives positive CHMP opinion recommending approval of remimazolam for the induction and maintenance of general anesthesia in adults27-Jan-2023 / 12:59 CET/CESTDisclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS...

Approval based on DESTINY-Breast04 results where Daiichi Sankyo and AstraZeneca's ENHERTU reduced the risk of disease progression or death by 50% and increased median overall survival by more than

An updated Q&A document for ICH M10 'Bioanalytical Method Validation and Study Sample Analysis’ has been published by the EMA.

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed ...

The European Commission has approved Enhertu as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.

This Week in Washington: House and Senate not in session, U.S. reaches debt-ceiling limit...

X-linked adrenoleukodystrophy (X-ALD) is the most common of a group of around 50 rare diseases of the white matter of the brain, the so-called leukodystrophies.