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18/07/2019: Pharegis implemented optimized procedures for state registration of pharmaceuticals in Eurasian Economic Union.
20/06/2019: Pharegis updated timelines and practical approaches for Russian and EEU GMP inspection applications and procedures.
03/04/2019: Renewed general monographs of Russian state pharmacopeia XIV ed. have been analyzed.
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Regulatory news
Drugs.com - New Drug Approvals
FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis
FDA Approves Orserdu (elacestrant) for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer
FDA Approves Jaypirca (pirtobrutinib) for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma
FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes
Brukinsa (zanubrutinib) Approved in the U.S. for Chronic Lymphocytic Leukemia
>
News and press releases
EMA update on shortages of antibiotics in the EU, , 26/01/2023
Actions to support the development of medicines for children, PDCO, 06/02/2023
Public consultation on a multi-stakeholder platform to improve clinical trials in the EU, , 03/02/2023
EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair, HMPC, 03/02/2023
>
Drugs.com - Clinical Trials
Wellmarker Bio Announces Clinical Trial Collaboration with MSD to evaluate WM-A1-3389 in combination with KEYTRUDA
SEOUL, South Korea , Feb. 7,...
Results in Phase 2 scleroderma study by Certa Therapeutics demonstrates improvement in more than 60% of patients
MELBOURNE, Australia, Feb....
New Publication Validates SeptiCyte RAPID as a Triaging Tool for COVID-19 Patients
SEATTLE and BRISBANE,...
Ionis announces GSK has advanced bepirovirsen into Phase 3 development
CARLSBAD, Calif., Feb. 1,...
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PharmaTimes: PharmaTimes Website RSS
Pharmacists to receive further mental health training
NICE fails to recommend Boehringer Ingelheim and Lilly Alliance’s empagliflozin
Vital funding established for Evonetix projects
EU approves AstraZeneca Forxiga for use across the EU
Kidney Cancer UK makes NICE plea
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