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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 Exxua (gepirone) for the Treatment of Major Depressive Disorder in Adults
U.S. FDA Approves Subcutaneous Administration of Takeda's Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
FDA Approves Bosutinib for Pediatric Patients with Chronic Myelogenous Leukemia
FDA Approves Ryzumvi (phentolamine) Ophthalmic Solution for the Treatment of Pharmacologically-Induced Mydriasis
FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial Infections
>
News and press releases
EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023
Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023
EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna, CHMP, 15/09/2023
>
Drugs.com - Clinical Trials
BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS
NEW YORK, Sept. 27, 2023...
IDEAYA Biosciences Receives Fast Track Designation for IDE161 in a Second Indication for the Treatment of Pretreated, Advanced or Metastatic HR+, Her2-, BRCA1/2 mutant Breast Cancer
SOUTH SAN FRANCISCO, Calif.,...
NMD Pharma initiates Phase II trial of NMD670 in Spinal Muscular Atrophy
Aarhus, Denmark, 26...
Reviva Announces Last Patient Evaluated in Pivotal Phase 3 RECOVER Trial for Brilaroxazine in Schizophrenia
CUPERTINO, Calif., Sept. 25,...
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PharmaTimes: PharmaTimes Website RSS
Women in Life Science Denmark launches leadership drive
AstraZeneca and SAS link up on AI and analytics
NHS Confederation research supports investment in NHS services
Oxford Biodynamics launches prostate screening test
UKHSA reaches vaccine deal with CSL Seqirus
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