UCB, a global biopharmaceutical company, today announced the CHMP (Committee for Medicinal Products for Human Use) has issued a positive opinion for the self-administration of RYSTIGGO® ...

There has hopefully been a breakthrough agreed by the EU and the UK in relation to ... regulatory issues that arise throughout the product life cycle, including maximising regulatory protections ...

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms ...

Serplulimab is the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC Serplulimab is the first and only anti-PD-1 mAb approved in the European Union (EU) ...

The investment case for Zhejiang Huahai, based within the province of Zhejiang, is that it is cheap based on current ...

The FDA action follows the finalisation of a 'reflection paper' by the EMA last year, setting out the EU regulator's thinking on the use of AI in the medicinal ... device's entire life cycle." ...

Schematic illustration of successes and failures in the commercialisation of ATMPs in the EU. As of March 2018, 10 products have ... improve the quality of life for a prolonged period of time. Here, ...

In November, Europe's Committee for Medicinal Products for Human Use (CHMP ... closely with the authorities toward approval in the EU." Welireg generated $139 million in sales during 2024 ...

The EU’s new Construction Products Regulation has come into effect ... Moreover, the ability to disassemble and repurpose prefabricated units at the end of their life cycle underscores the ...

Actuate Therapeutics has gained orphan medicinal product designation ... is awarded to therapies for life-threatening or chronically debilitating diseases that affect no more than two in 10,000 ...

and may increase costs for product manufacturers. End-of-life management is complicated by flame retardants, which can prevent safe recycling. For example, sustainability efforts like the European ...