This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
Company intends to increase sales in the UK to approximately 2 million Euros by focusing on seven molecules which are already registered in the country
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in
NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.
Companies concluded memorandum of understanding that Takeda will continue to provide distribution support for the Moderna COVID-19 vaccines for a transitional period
Clearing 19 biologics for Europe market
First-in-class topical androgen receptor inhibitor marks Glenmark’s first New Chemical Entity (NCE) launch in Europe
The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy
The approval marks a major milestone in the global fight against antimicrobial resistance
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