announced it has received notice of a positive opinion from the European Medicines Agency (EMA) for Orphan Medicinal Product Designation (OMPD) following its application for its lead drug candidate, ...
Neurizon has been buoyed by the receipt of a positive opinion from the European Medicines Agency in relation to its ...
In addition, we have completed marketing authorization application (MAA) submissions for sebetralstat to the European ...
EBR Systems is among ASX healthcare stocks with upcoming catalysts, expecting feedback on a FDA substantive review expected ...
While the final decision is set for next month, biotech player Neurizon’s (ASX:NUZ) hopes have been lifted with a view ...
Positive results from completed Phase 2 study of mavorixafor in chronic neutropenia (CN) announced todayPivotal Phase 3 trial of mavorixafor in ...
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported a ...
Amtagvi Infusions: A total of 146 patients have been infused with Amtagvi since the first commercial infusion in April 2024, including 25 patients infused in the second quarter, 82 patients infused in ...
The global periodontal disease treatment market is projected to reach USD 3.63 billion by 2030 from USD 2.58 billion in 2024, growing at a CAGR of 5.9% during the forecast period 2024-2030. In all the ...
The FDA said it was “unable to approve the supplemental new drug application (sNDA ... The EC made its decision following the ...
If approved by the FDA, Darzalex Faspro may be the first treatment for smoldering multiple myeloma as compared to treating the disease once it progresses.