Biogen wins European first for depression drug Zurzuvae
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
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The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
Winners of this year's awards will be revealed during the opening of CPHI Frankfurt 2025.
The deal with the US biopharma could help address metabolic dysfunction-associated steatohepatitis, one of the most prevalent comorbidities of obesity.
The new $5 billion manufacturing site is set to become the company’s first integrated facility for API and drug product manufacturing.
Expanding its collaboration with the US biotech will add novel molecular glue degrader-based medicines to the pharma company’s pipeline.
The ICH Assembly’s decision supports progress in promoting international standards for safety assessment of medicines.
The novel approach could enhance quality testing applications in pharmaceutical manufacturing.
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
Gains access to potential breakthrough atherosclerotic cardiovascular disease biologic therapy pacibekitug.
As an important policy tool, the new editions by the WHO mark a “significant” step in broadening access to new medicines with proven clinical benefits.
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
Significant investment in advanced technologies Is expected to support global adoption of mass spectrometry in the next five years.
European Parliament's SANT Committee urges for greater control on medicine provisions to help strengthen security of supply.
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
2 September 2025 | By FUJIFILM Wako Europe GmbH
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