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® ...

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 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, ...

Participants in many clinical trials are suffering from life-threatening ... [i] European Commission, Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human ...

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 ...

EU regulators have issued a positive opinion for the extension of the market authorization for subcutaneous formulation of ...

Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...

Biogen (BIIB) and Eisai announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as ...

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...

was a transformative year for the products law landscape, marked by sweeping regulatory shifts, emerging trends, and heightened ...

as well as universal and variable life insurance products. Who's this for: MassMutual offers several whole life insurance options, including a survivorship whole life insurance policy. The Whole ...