Orphan Designation offers 10 years of market exclusivity in Europe upon product approval, along with additional regulatory and commercial benefits Positions Neurizon to advance the development of ...

Neurizon has been buoyed by the receipt of a positive opinion from the European Medicines Agency in relation to its ... Read ...

Johnson & Johnson announced the submission of regulatory applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of a new indication for Darzalex ...

Syncona Ltd (SYNC.L) said that its portfolio company Autolus Therapeutics announced that the U.S. Food and Drug Administration has ...

J&J’s filing is based on results from the phase 3 AQUILA trial. Among 390 patients with high-risk smoldering multiple myeloma ...

While the final decision is set for next month, biotech player Neurizon’s (ASX:NUZ) hopes have been lifted with a view ...

Interim analysis for Study 1 of Essential3 Phase 3 program for ulixacaltamide in essential tremor (ET) confirmed for Q1 2025; NDA filing ...

Shelley Gandhi Joins Firm – Headlines ELIQUENT’s Expanded Pharmacovigilance Service Offerings ...

Patient involvement in health policy is a patchwork across the EU. Putting the lived experience front and centre of policy-making was prioritised at a recent high-level policy event organised by the ...

Directive Might Cause Massive Medicine Shortages Affecting Millions Of Patients Across Europe ...

Panax ginseng shows highest effectiveness in treating Alzheimer's. Learn more about AVXL's blarcamesine and SAVA's simufilam ...

The company is also making strides in international markets, with the disposable pen needle (GanleeFine®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection ...