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.
Global industry news
Novo's Ozempic scores major win with heart-helping FDA approval. Is Rybelsus next?
Hengrui's Sun Piaoyang, China's richest pharma leader, steps down after 30-year run—sort of
FiercePharmaAsia—Astellas' cell therapy deal; Takeda's €398M tax bill; Lilly-shared PD-1 in NSCLC
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Drugs.com - New Drug Approvals
FDA Approves Ozempic (semaglutide) for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease
FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia
FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment
FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor
FDA Approves Expanded Indication of Mycamine (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age
News and press releases
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020, PRAC, 17/01/2020
EMA suspends Picato as a precaution while review of skin cancer risk continues, PRAC, 17/01/2020
PRAC confirms four-week limit for use of high-strength estradiol creams, PRAC, 17/01/2020
EMA welcomes new Head of Information Management Division , , 16/01/2020
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