BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced that the Committee for Medicinal Products for ...

AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously ...

FDA and EMA discussions completed to support a potential accelerated approval path in both US and EU Orphan Drug Designation for PCNSL granted in both US and EU Management ...

Here are the critical medicines in short supply in the EU, according to the latest available information from the EMA and ...

U.S. commercial launch progressing on track with 33 authorized treatment centers as of March 19, 2025, following US FDA approval on November 8, 2024Obe-cel MHRA and EMA marketing authorizations ...

Italy, Netherlands, Spain, and Sweden. OST-HER2 has received Fast Track and Orphan Drug designations from the European Medicines Agency. About OS Therapies OS Therapies is a clinical stage ...

FDA & EMA approvals for rare genetic diseases are fast and require clinical studies with small number of patients Ramat Gan, Israel, March ...

Neurim Pharmaceuticals ("Neurim") announces that the European Commission has approved the extension of the indication to include the treatment of insomnia in children with attention deficit ...

The United States, which has a testy relationship with the Myanmar military has said it would provide assistance.

Amid readouts from the Muscular Dystrophy Association’s annual meeting, the Clinical Trials Arena evaluates five Duchenne trials in 2025.