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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
- Novartis Tafinlar + Mekinist Approved by FDA for Pediatric Patients with BRAF V600E Low-Grade Glioma
- FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome
- FDA Approves Zavzpret (zavegepant) Nasal Spray for the Acute Treatment of Migraine
- FDA Broadens Indication for Verzenio (abemaciclib) in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer
- FDA Approves Skyclarys (omaveloxolone) for the Treatment of Friedreich’s Ataxia
News and press releases
- EMA Management Board: highlights of March 2023 meeting, MB, 17/03/2023
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023, PRAC, 17/03/2023
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022, CVMP, 09/12/2022
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 February 2023, CVMP, 17/02/2023
Drugs.com - Clinical Trials
- First Subjects Dosed in Phase 1 Clinical Trial of VXX-401, Investigational Anti-PCSK9 Vaccine to Treat Hypercholesterolemia CAPE CANAVERAL, Fla., March...
- Phase 3 Study Shows XTANDI plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer NEW YORK and TOKYO, March...
- Merck Provides Update from Open-Label Arm of Phase 2 KeyVibe-002 Trial Evaluating MK-7684A, a Coformulation of Vibostolimab and Pembrolizumab, in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) RAHWAY, N.J.--(BUSINESS...
- Arbutus Doses First Subject in Phase 1 Clinical Trial with its Oral RNA Destabilizer, AB-161 WARMINSTER, Pa., March 16,...