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October 13, 2023
By Chris Wack Cidara Therapeutics and Mundipharma said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted...
October 13, 2023
The decision comes after Amylyx in June requested a formal re-examination of the initial negative opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The drug, which has been approved by the U.S. Food and Drug Administration (FDA), is a combination of generic compounds sodium phenylbutyrate and taurursodiol that work together to prevent nerve cells in the brain and spinal cord from dying prematurely. Amylyx's drug has also b...
October 13, 2023
By Denny Jacob BeiGene's brukinsa received a positive opinion recommending its approval from an European Medicines Agency committee. The biotechnology...
October 13, 2023
(RTTNews) - Amylyx Pharmaceuticals Inc. (AMLX) said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicin...
October 13, 2023
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib in combination with obinutuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 lines of systemic treatment.
October 12, 2023
The CHMP issues an opinion in favour of granting an EU marketing authorisation for Elucirem™ with the indication of use for magnetic resonance imaging with contrast enhancement in adults and...
October 12, 2023
The CHMP issues an opinion in favour of granting an EU marketing authorisation for Elucirem™ (Gadopiclenol)with the indication of use for magnetic...
October 12, 2023
12.10.2023 - The CHMP issues an opinion in favour of granting an EU marketing authorisation for Elucirem (Gadopiclenol)with the indication of use for magnetic resonance imaging with contrast enhancement in adults and children aged 2 years and over If ... Seite 1
October 12, 2023
/PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of...
October 10, 2023
In September 2023, the European Medicines Agency (EMA) relaunched its Policy 0070 on publication of clinical data for medicinal products for human...