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Delandistrogene moxeparvovec, sold under the brand name Elevidys, is a recombinant gene therapy used for the treatment of Duchenne muscular dystrophy. [3] It is designed to deliver into the body a gene that leads to production of Elevidys micro-dystrophin that contains selected domains of the dystrophin protein present in normal muscle cells. [3]
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
AstraZeneca submitted its application for conditional marketing authorisation to the European Medicines Agency (EMA) on 12 January 2021, [24] EMA subsequently approved the use of the Oxford–AstraZeneca vaccine on 29 January, [1] joining the Pfizer vaccine, approved on 21 December 2020, [25] and the Moderna vaccine on 6 January 2021. [26]
In July 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended a conditional marketing authorization for epcoritamab (Tepkinly). [14] It was approved for medical use in the European Union in September 2023. [5] The EMA granted orphan drug designation to epcoritamab in both February and June 2022 ...
Pfizer's BOSULIF® (bosutinib) Receives Conditional Marketing Authorization From The European Commission NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. announced today that the European Commission (EC ...
In May 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Durveqtix, intended for the treatment of severe and moderately severe hemophilia B. [6] [12] The applicant for this medicinal ...
In December 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Hemgenix, intended for the treatment of severe and moderately severe hemophilia B. [11] The applicant for this medicinal product is CSL Behring GmbH. [11]
Conditional approval also often comes into play with home construction loans. If you are building a home or buying land to build a home on, the developer or general contractor might demand the ...